Trial Outcomes & Findings for Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine (NCT NCT03525119)
NCT ID: NCT03525119
Last Updated: 2022-08-19
Results Overview
Seroprotection is defined as serum anti-HAV antibody levels ≥12.5 mIU/mL, measured by enzyme-linked immunosorbent assay (ELISA). Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels \<12.5 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes \<10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
900 participants
Primary outcome timeframe
One month post first vaccination (Day 30)
Results posted on
2022-08-19
Participant Flow
Participants took part in the study at 10 investigative sites in United Kingdom from 16-May-2018 to 09-Jul-2019.
Healthy participants were randomized in 1:1:1 ratio in 3 parallel groups: Group 1 received 1 dose of Hepatitis A Virus (HAV) vaccine and Tetravalent Dengue Vaccine Candidate (TDV) placebo matching injection, Group 2 received 2 doses of TDV and HAV vaccine placebo matching injection and Group 3 received 1 dose of HAV vaccine and 2 doses of TDV.
Participant milestones
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
300
|
|
Overall Study
Safety Population
|
299
|
300
|
298
|
|
Overall Study
COMPLETED
|
260
|
261
|
257
|
|
Overall Study
NOT COMPLETED
|
40
|
39
|
43
|
Reasons for withdrawal
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
32
|
33
|
37
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
2
|
|
Overall Study
Reason not Specified
|
2
|
1
|
2
|
|
Overall Study
Randomized but not Vaccinated
|
1
|
0
|
2
|
Baseline Characteristics
Number analyzed is the number of participants with data available at Baseline.
Baseline characteristics by cohort
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=300 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
Total
n=900 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 12.03 • n=300 Participants
|
36.0 years
STANDARD_DEVIATION 11.88 • n=300 Participants
|
35.5 years
STANDARD_DEVIATION 11.94 • n=300 Participants
|
35.4 years
STANDARD_DEVIATION 11.95 • n=900 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=300 Participants
|
120 Participants
n=300 Participants
|
90 Participants
n=300 Participants
|
317 Participants
n=900 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=300 Participants
|
180 Participants
n=300 Participants
|
210 Participants
n=300 Participants
|
583 Participants
n=900 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=300 Participants
|
4 Participants
n=300 Participants
|
1 Participants
n=300 Participants
|
11 Participants
n=900 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
290 Participants
n=300 Participants
|
293 Participants
n=300 Participants
|
296 Participants
n=300 Participants
|
879 Participants
n=900 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=300 Participants
|
3 Participants
n=300 Participants
|
3 Participants
n=300 Participants
|
10 Participants
n=900 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
1 Participants
n=900 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=300 Participants
|
9 Participants
n=300 Participants
|
11 Participants
n=300 Participants
|
25 Participants
n=900 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=300 Participants
|
1 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
2 Participants
n=900 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=300 Participants
|
4 Participants
n=300 Participants
|
6 Participants
n=300 Participants
|
16 Participants
n=900 Participants
|
|
Race (NIH/OMB)
White
|
280 Participants
n=300 Participants
|
281 Participants
n=300 Participants
|
279 Participants
n=300 Participants
|
840 Participants
n=900 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=300 Participants
|
4 Participants
n=300 Participants
|
4 Participants
n=300 Participants
|
15 Participants
n=900 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=300 Participants
|
1 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
1 Participants
n=900 Participants
|
|
Region of Enrollment
United Kingdom
|
300 Participants
n=300 Participants
|
300 Participants
n=300 Participants
|
300 Participants
n=300 Participants
|
900 Participants
n=900 Participants
|
|
Height
|
173.80 cm
STANDARD_DEVIATION 9.299 • n=299 Participants • Number analyzed is the number of participants with data available at Baseline.
|
172.12 cm
STANDARD_DEVIATION 9.163 • n=300 Participants • Number analyzed is the number of participants with data available at Baseline.
|
173.00 cm
STANDARD_DEVIATION 9.110 • n=297 Participants • Number analyzed is the number of participants with data available at Baseline.
|
172.97 cm
STANDARD_DEVIATION 9.207 • n=896 Participants • Number analyzed is the number of participants with data available at Baseline.
|
|
Weight
|
79.24 kg
STANDARD_DEVIATION 15.547 • n=299 Participants • Number analyzed is the number of participants with data available at Baseline.
|
78.18 kg
STANDARD_DEVIATION 15.570 • n=300 Participants • Number analyzed is the number of participants with data available at Baseline.
|
78.92 kg
STANDARD_DEVIATION 15.243 • n=297 Participants • Number analyzed is the number of participants with data available at Baseline.
|
78.78 kg
STANDARD_DEVIATION 15.444 • n=896 Participants • Number analyzed is the number of participants with data available at Baseline.
|
|
Body Mass Index (BMI)
|
26.16 kg/m^2
STANDARD_DEVIATION 4.256 • n=299 Participants • Number analyzed is the number of participants with data available at Baseline.
|
26.31 kg/m^2
STANDARD_DEVIATION 4.354 • n=300 Participants • Number analyzed is the number of participants with data available at Baseline.
|
26.29 kg/m^2
STANDARD_DEVIATION 4.283 • n=297 Participants • Number analyzed is the number of participants with data available at Baseline.
|
26.25 kg/m^2
STANDARD_DEVIATION 4.293 • n=896 Participants • Number analyzed is the number of participants with data available at Baseline.
|
|
Baseline Seroprotection Against HAV
Yes
|
31 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
38 Participants
n=121 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
30 Participants
n=122 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
99 Participants
n=361 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
|
Baseline Seroprotection Against HAV
No
|
87 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
83 Participants
n=121 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
92 Participants
n=122 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
262 Participants
n=361 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
|
Baseline Seropositivity Status for Dengue
Seropositive
|
11 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
8 Participants
n=119 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
9 Participants
n=120 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
28 Participants
n=357 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
|
Baseline Seropositivity Status for Dengue
Seronegative
|
107 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
111 Participants
n=119 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
111 Participants
n=120 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
329 Participants
n=357 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline.
|
|
Baseline Seropositivity Rate for Each Dengue Serotype
DENV-1
|
6 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
6 Participants
n=119 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
5 Participants
n=120 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
17 Participants
n=357 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
|
Baseline Seropositivity Rate for Each Dengue Serotype
DENV-2
|
4 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
2 Participants
n=119 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
5 Participants
n=120 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
11 Participants
n=357 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
|
Baseline Seropositivity Rate for Each Dengue Serotype
DENV-3
|
4 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
1 Participants
n=119 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
1 Participants
n=120 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
6 Participants
n=357 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
|
Baseline Seropositivity Rate for Each Dengue Serotype
DENV-4
|
1 Participants
n=118 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
2 Participants
n=119 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
2 Participants
n=120 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
5 Participants
n=357 Participants • Number analyzed is the number of participants from Immunogenicity Subset, with data available for analyses at Baseline. Participants are repeated across categories as seropositivity for more than serotype is reported.
|
PRIMARY outcome
Timeframe: One month post first vaccination (Day 30)Population: HAV PPS: All HAV \& DENV-naïve participants in the immunogenicity subset who received at least 1 dose of trial vaccine, with available Day 1 and Day 30 HAV immunogenicity measurements, and who have no major protocol violations.
Seroprotection is defined as serum anti-HAV antibody levels ≥12.5 mIU/mL, measured by enzyme-linked immunosorbent assay (ELISA). Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels \<12.5 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes \<10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=68 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=66 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=79 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30
|
97.1 percentage of participants
Interval 89.8 to 99.6
|
9.1 percentage of participants
Interval 3.4 to 18.7
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
SECONDARY outcome
Timeframe: One month post first vaccination (Day 30) and one month post second vaccination (Day 120)Population: TDV PPS: All HAV \& DENV-naïve participants in the immunogenicity subset who received at least 1 dose of trial vaccine, with available Day 1 and at least 1 post-dose immunogenicity measurements, and who have no major protocol violations. Number analyzed are participants with data available at the given timepoint.
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=66 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=63 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=67 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 1, Day 30
|
5.0 titer
Lower and upper limits of CI could not be evaluated as titers were below the lower limit of detection (LLOD).
|
108.2 titer
Interval 69.2 to 169.1
|
152.5 titer
Interval 104.4 to 222.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 2, Day 30
|
6.0 titer
Interval 5.1 to 7.1
|
2897.9 titer
Interval 1469.2 to 5715.6
|
3960.0 titer
Interval 2310.7 to 6786.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 3, Day 30
|
5.3 titer
Interval 4.7 to 5.8
|
95.4 titer
Interval 59.5 to 153.2
|
140.5 titer
Interval 96.8 to 203.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 4, Day 30
|
5.0 titer
Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
|
74.3 titer
Interval 49.0 to 112.9
|
142.1 titer
Interval 90.5 to 223.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 1, Day 120
|
5.0 titer
Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
|
171.3 titer
Interval 104.5 to 281.0
|
173.7 titer
Interval 120.1 to 251.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 2, Day 120
|
5.7 titer
Interval 4.9 to 6.7
|
2064.1 titer
Interval 1459.7 to 2918.9
|
1764.3 titer
Interval 1238.6 to 2513.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 3, Day 120
|
5.0 titer
Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
|
83.8 titer
Interval 59.0 to 119.0
|
92.6 titer
Interval 71.3 to 120.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline
DENV 4, Day 120
|
5.0 titer
Lower and upper limits of CI could not be evaluated as titers were below the LLOD.
|
56.1 titer
Interval 41.0 to 76.7
|
81.4 titer
Interval 59.2 to 111.8
|
SECONDARY outcome
Timeframe: One month post first vaccination (Day 30) and one month post second vaccination (Day 120)Population: TDV PPS: All HAV \& DENV-naïve participants in the immunogenicity subset who received at least 1 dose of trial vaccine, with available Day 1 and at least 1 post-dose immunogenicity measurements, and who have no major protocol violations. Number analyzed are participants with data available at the given timepoint.
Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=66 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=63 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=67 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 1, Day 30
|
0 percentage of participants
Interval 0.0 to 5.9
|
88.3 percentage of participants
Interval 77.4 to 95.2
|
95.4 percentage of participants
Interval 87.1 to 99.0
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 2, Day 30
|
8.2 percentage of participants
Interval 2.7 to 18.1
|
91.7 percentage of participants
Interval 81.6 to 97.2
|
96.9 percentage of participants
Interval 89.3 to 99.6
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 3, Day 30
|
1.6 percentage of participants
Interval 0.0 to 8.8
|
85.0 percentage of participants
Interval 73.4 to 92.9
|
95.4 percentage of participants
Interval 87.1 to 99.0
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 4, Day 30
|
0 percentage of participants
Interval 0.0 to 5.9
|
86.7 percentage of participants
Interval 75.4 to 94.1
|
90.8 percentage of participants
Interval 81.0 to 96.5
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 1, Day 120
|
0 percentage of participants
Interval 0.0 to 7.1
|
100.0 percentage of participants
Interval 93.5 to 100.0
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 2, Day 120
|
6.0 percentage of participants
Interval 1.3 to 16.5
|
100.0 percentage of participants
Interval 93.5 to 100.0
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 3, Day 120
|
0 percentage of participants
Interval 0.0 to 7.1
|
92.7 percentage of participants
Interval 82.4 to 98.0
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
|
Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120
DENV 4, Day 120
|
0 percentage of participants
Interval 0.0 to 7.1
|
96.4 percentage of participants
Interval 87.5 to 99.6
|
96.8 percentage of participants
Interval 88.8 to 99.6
|
SECONDARY outcome
Timeframe: One month post first vaccination (Day 30)Population: HAV PPS: All HAV \& DENV-naïve participants in the immunogenicity subset who received at least 1 dose of trial vaccine, with available Day 1 and Day 30 HAV immunogenicity measurements, and who have no major protocol violations.
GMC of anti-HAV antibodies were measured by ELISA.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=68 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=66 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=79 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMC) of Anti-HAV Antibodies at Day 30 in Participants HAV/DENV-naive at Baseline
|
82.1 mIU/mL
Interval 62.9 to 107.1
|
6.7 mIU/mL
Interval 6.4 to 7.2
|
93.0 mIU/mL
Interval 76.1 to 113.6
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccinationPopulation: Safety Set included all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available for the specific category. Only categories for which there was at least 1 participant are reported.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm) and swelling (edema/induration) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm ). The percentages were rounded off to the first decimal place.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination IM,Any Local AEs
|
45.0 percentage of participants
|
15.4 percentage of participants
|
49.1 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Pain-Any
|
44.6 percentage of participants
|
14.4 percentage of participants
|
48.4 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Pain-Mild
|
38.1 percentage of participants
|
13.0 percentage of participants
|
43.9 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Pain-Moderate
|
6.6 percentage of participants
|
1.0 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Pain-Severe
|
0 percentage of participants
|
0.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Erythema-Any
|
2.4 percentage of participants
|
2.1 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Erythema-Mild
|
1.7 percentage of participants
|
1.4 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Swelling-Mild
|
1.4 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC,Any Local AEs
|
15.6 percentage of participants
|
47.3 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination SC, Pain-Any
|
14.2 percentage of participants
|
40.4 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination SC, Pain-Mild
|
12.5 percentage of participants
|
35.6 percentage of participants
|
36.1 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC, Pain-Moderate
|
1.7 percentage of participants
|
4.8 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC, Erythema-Any
|
1.7 percentage of participants
|
16.8 percentage of participants
|
14.4 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC, Erythema-Moderate
|
0 percentage of participants
|
1.0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC, Swelling-Any
|
1.0 percentage of participants
|
2.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC, Swelling-Mild
|
0.7 percentage of participants
|
2.7 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Pain-Moderate
|
0.4 percentage of participants
|
2.7 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Pain-Severe
|
0 percentage of participants
|
1.1 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Erythema-Any
|
0.4 percentage of participants
|
12.9 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Erythema-Mild
|
0.4 percentage of participants
|
12.2 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Erythema-Moderate
|
0 percentage of participants
|
0.8 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Swelling-Any
|
0.8 percentage of participants
|
4.6 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Erythema-Moderate
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, IM, Swelling-Any
|
1.8 percentage of participants
|
0.3 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, SC, Erythema-Mild
|
1.0 percentage of participants
|
15.8 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Any Local AEs
|
11.0 percentage of participants
|
37.9 percentage of participants
|
41.0 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Pain-Any
|
10.6 percentage of participants
|
34.7 percentage of participants
|
37.8 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Pain-Mild
|
10.2 percentage of participants
|
30.9 percentage of participants
|
33.9 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Swelling-Mild
|
0.8 percentage of participants
|
3.4 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, SC,Swelling-Moderate
|
0 percentage of participants
|
0.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 14 days after each vaccinationPopulation: Safety Set included all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available for the specific category. Only categories for which there was at least 1 participant are reported.
Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Any Systemic AEs
|
47.4 percentage of participants
|
44.2 percentage of participants
|
49.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Headache-Any
|
28.7 percentage of participants
|
32.5 percentage of participants
|
31.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Headache-Mild
|
19.0 percentage of participants
|
22.3 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Headache-Moderate
|
8.7 percentage of participants
|
8.2 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Headache-Severe
|
1.0 percentage of participants
|
2.1 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Asthenia-Any
|
17.0 percentage of participants
|
15.8 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Asthenia-Mild
|
12.8 percentage of participants
|
9.2 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Asthenia-Moderate
|
4.2 percentage of participants
|
5.5 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Asthenia-Severe
|
0 percentage of participants
|
1.0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Malaise-Any
|
17.6 percentage of participants
|
21.2 percentage of participants
|
21.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Malaise-Moderate
|
5.2 percentage of participants
|
5.8 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Malaise-Severe
|
1.0 percentage of participants
|
1.7 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Myalgia-Any
|
29.4 percentage of participants
|
22.9 percentage of participants
|
33.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Myalgia-Mild
|
23.9 percentage of participants
|
16.4 percentage of participants
|
27.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Myalgia-Moderate
|
5.2 percentage of participants
|
6.2 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Myalgia-Severe
|
0.3 percentage of participants
|
0.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Fever-Any
|
1.7 percentage of participants
|
2.7 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Fever-38.5-<39.0
|
0.3 percentage of participants
|
0.7 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Fever-39.0-<39.5
|
0 percentage of participants
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Fever-≥41.0
|
0 percentage of participants
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Any Systemic AEs
|
27.6 percentage of participants
|
30.2 percentage of participants
|
33.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Headache-Any
|
17.7 percentage of participants
|
17.2 percentage of participants
|
22.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Headache-Mild
|
13.0 percentage of participants
|
12.6 percentage of participants
|
14.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Headache-Moderate
|
4.3 percentage of participants
|
3.4 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Headache-Severe
|
0.4 percentage of participants
|
1.1 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Asthenia-Any
|
9.8 percentage of participants
|
7.6 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Asthenia-Mild
|
7.5 percentage of participants
|
5.0 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Asthenia-Moderate
|
2.4 percentage of participants
|
2.7 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Asthenia-Severe
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Malaise-Any
|
14.6 percentage of participants
|
14.9 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Malaise-Mild
|
10.2 percentage of participants
|
9.9 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Malaise-Moderate
|
3.1 percentage of participants
|
3.8 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Malaise-Severe
|
1.2 percentage of participants
|
1.1 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Myalgia-Any
|
12.6 percentage of participants
|
15.6 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Myalgia-Mild
|
10.2 percentage of participants
|
13.0 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Fever-Any
|
3.6 percentage of participants
|
1.1 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Fever-38.0-<38.5
|
3.2 percentage of participants
|
0.4 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Fever-38.5-<39.0
|
0 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Fever-39.5-<40.0
|
0.4 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Malaise-Mild
|
11.4 percentage of participants
|
13.7 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After First Vaccination, Fever-38.0-<38.5
|
1.4 percentage of participants
|
2.1 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Myalgia-Moderate
|
2.0 percentage of participants
|
1.9 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
After Second Vaccination, Myalgia-Severe
|
0.4 percentage of participants
|
0.8 percentage of participants
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days (Day of Vaccination+27 Subsequent Days) after each vaccinationPopulation: Safety Set included all participants who received at least 1 dose of 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 trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
After First Vaccination
|
14.7 percentage of participants
|
17.0 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
After Second Vaccination
|
14.4 percentage of participants
|
10.0 percentage of participants
|
11.7 percentage of participants
|
SECONDARY outcome
Timeframe: From the first vaccination on Day 1 until the end of the trial (Day 270)Population: Safety Set included all participants who received at least 1 dose of trial vaccine.
A SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) 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 |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
0.7 percentage of participants
|
2.7 percentage of participants
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: From the first vaccination on Day 1 until the end of the trial (Day 270)Population: Safety Set included all participants who received at least 1 dose of trial vaccine.
MAAEs are defined as AEs leading to a medical visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Outcome measures
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 Participants
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 Participants
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 Participants
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Percentage of Participants With Medically Attended AEs (MAAEs)
|
23.1 percentage of participants
|
21.0 percentage of participants
|
20.1 percentage of participants
|
Adverse Events
HAV Vaccine 1.0 ml + Placebo/ Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
TDV 0.5 ml + Placebo/ TDV 0.5 ml
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 participants at risk
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 participants at risk
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 participants at risk
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.33%
1/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.33%
1/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Infections and infestations
Wound infection
|
0.33%
1/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage II
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.33%
1/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.00%
0/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
0.34%
1/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
Other adverse events
| Measure |
HAV Vaccine 1.0 ml + Placebo/ Placebo
n=299 participants at risk
HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + Placebo/ TDV 0.5 ml
n=300 participants at risk
TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
n=298 participants at risk
TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.0%
9/299 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
2.7%
8/300 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
3.7%
11/298 • All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
Safety Set included all participants who received at least 1 dose of trial vaccine.
|
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