Trial Outcomes & Findings for Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America (NCT NCT01187433)
NCT ID: NCT01187433
Last Updated: 2022-03-21
Results Overview
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Before and 28 days after each injection
Results posted on
2022-03-21
Participant Flow
Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.
A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
50
|
|
Overall Study
COMPLETED
|
89
|
46
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=50 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
12.7 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
12.7 Years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
12.7 Years
STANDARD_DEVIATION 2.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
100 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Seropositivity was assessed in the Full Analysis Set.
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=49 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1 (n=99, 49)
|
59.6 Percentage of participants
|
63.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 1 (n=99, 49)
|
79.8 Percentage of participants
|
69.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 2 (n=94, 47)
|
80.9 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post Injection 2 (n=94, 47)
|
95.7 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 3 (n=90, 46)
|
78.9 Percentage of participants
|
69.6 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3 (n=89, 46)
|
96.6 Percentage of participants
|
69.6 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1 (n=99, 49)
|
65.7 Percentage of participants
|
67.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 1 (n=99, 49)
|
80.8 Percentage of participants
|
67.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 2 (n=94, 47)
|
80.9 Percentage of participants
|
74.5 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2 (n=94, 47)
|
98.9 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 3 (n=90, 46)
|
85.6 Percentage of participants
|
76.1 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3 (n=89, 46)
|
98.9 Percentage of participants
|
76.1 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1 (n=99, 49)
|
62.6 Percentage of participants
|
65.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 1 (n=99, 49)
|
92.9 Percentage of participants
|
67.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 2 (n=94, 47)
|
89.4 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2 (n=94, 47)
|
100.0 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 3 (n=89, 46)
|
94.4 Percentage of participants
|
71.7 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3 (n=89, 46)
|
100.0 Percentage of participants
|
73.9 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1 (n=99, 49)
|
47.5 Percentage of participants
|
51 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post -njection 1 (n=99, 48)
|
89.9 Percentage of participants
|
58.3 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 2 (n=94, 47)
|
92.6 Percentage of participants
|
57.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2 (n=94, 47)
|
100.0 Percentage of participants
|
59.6 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 3 (n=88, 46)
|
97.7 Percentage of participants
|
69.6 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3 (n=89, 46)
|
100.0 Percentage of participants
|
73.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Seropositivity was assessed in the Full Analysis Set.
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=80 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=41 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 1 (n=80, 41)
|
93.8 Percentage of participants
|
80.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 2 (n=78, 39)
|
92.3 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 3 (n=74, 38)
|
91.9 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3 (n=73, 38)
|
98.6 Percentage of participants
|
81.6 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1 (n=80, 41)
|
81.3 Percentage of participants
|
80.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1 (n=80, 41)
|
73.8 Percentage of participants
|
75.6 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 1 (n=80, 41)
|
88.8 Percentage of participants
|
82.9 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 2 (n=78, 39)
|
91.0 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 3 (n=74, 38)
|
87.8 Percentage of participants
|
81.6 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3 (n=73, 38)
|
100.0 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1 (n=80, 41)
|
77.5 Percentage of participants
|
78 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 1 (n=80, 41)
|
95.0 Percentage of participants
|
80.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 2 (n=78, 39)
|
93.6 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 3 (n=74, 38)
|
97.3 Percentage of participants
|
84.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3 (n=73, 38)
|
100.0 Percentage of participants
|
86.8 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1 (n=80, 41)
|
58.8 Percentage of participants
|
61 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 1 (n=80, 40)
|
95.0 Percentage of participants
|
70 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 2 (n=78, 39)
|
94.9 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
71.8 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 3 (n=73, 38)
|
98.6 Percentage of participants
|
81.6 Percentage of participants
|
|
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3 (n=73, 38)
|
100.0 Percentage of participants
|
84.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Before and 28 Days after each injectionPopulation: Seropositivity was assessed in the Full Analysis Set.
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=19 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=8 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 1 (n=19, 8)
|
42.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 2 (n=16, 8)
|
31.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2 (n=16, 8)
|
75.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 3 (n=16, 8)
|
37.5 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3 (n=16, 8)
|
87.5 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 1 (n=19, 8)
|
26.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 2 (n=16, 8)
|
25.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2 (n=16, 8)
|
93.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 3 (n=16, 8)
|
56.3 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3 (n=16, 8)
|
93.8 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 1 (n=19, 8)
|
84.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 2 (n=16, 8)
|
68.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2 (n=16, 8)
|
100.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 3 (n=15, 8)
|
80.0 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3 (n=16, 8)
|
100.0 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 1 (n=19, 8)
|
68.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 2 (n=16, 8)
|
81.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2 (n=16, 8)
|
100.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 3 (n=15, 8)
|
93.3 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3 (n=16, 8)
|
100.0 Percentage of participants
|
25 Percentage of participants
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Seropositivity was assessed in the Full Analysis Set.
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=49 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 1 (n=99, 49)
|
97.0 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 2 (n=94, 47)
|
94.7 Percentage of participants
|
74.5 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 2 (n=94, 47)
|
100.0 Percentage of participants
|
74.5 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 3 (n=90, 46)
|
98.9 Percentage of participants
|
78.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 3 (n=89, 46)
|
100.0 Percentage of participants
|
78.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 1 (n=99, 49)
|
62.6 Percentage of participants
|
67.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 1 (n=99, 49)
|
91.9 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 2 (n=94, 47)
|
92.6 Percentage of participants
|
74.5 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 2 (n=94, 47)
|
100.0 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 3 (n=90, 46)
|
91.1 Percentage of participants
|
73.9 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 3 (n=89, 46)
|
100.0 Percentage of participants
|
76.1 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 1 (n=99, 49)
|
56.6 Percentage of participants
|
61.2 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 1 (n=99, 49)
|
81.8 Percentage of participants
|
65.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 2 (n=94, 47)
|
81.9 Percentage of participants
|
72.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 2 (n=94, 47)
|
98.9 Percentage of participants
|
70.2 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 3 (n=90, 46)
|
86.7 Percentage of participants
|
71.7 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 3 (n=89, 46)
|
98.9 Percentage of participants
|
71.7 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 1 (n=99, 49)
|
47.5 Percentage of participants
|
46.9 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 1 (n=99, 49)
|
72.7 Percentage of participants
|
53.1 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 2 (n=94, 47)
|
74.5 Percentage of participants
|
55.3 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 2 (n=94, 47)
|
95.7 Percentage of participants
|
59.6 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 3 (n=90, 46)
|
76.7 Percentage of participants
|
63 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 3 (n=89, 46)
|
96.6 Percentage of participants
|
67.4 Percentage of participants
|
|
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 1 (n=99, 49)
|
68.7 Percentage of participants
|
71.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Seropositivity was assessed in the Full Analysis Set.
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=80 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=41 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 1 (n=80, 41)
|
85.0 Percentage of participants
|
85.4 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 1 (n=80, 41)
|
97.5 Percentage of participants
|
85.4 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 2 (n=78, 39)
|
97.4 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 3 (n=74, 38)
|
100.0 Percentage of participants
|
92.1 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 3 (n=73, 38)
|
100.0 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 1 (n=80, 41)
|
77.5 Percentage of participants
|
80.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 1 (n=80, 41)
|
95.0 Percentage of participants
|
85.4 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 2 (n=78, 39)
|
97.4 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 3 (n=74, 38)
|
95.9 Percentage of participants
|
86.8 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 3 (n=73, 38)
|
100.0 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 1 (n=80, 41)
|
70.0 Percentage of participants
|
73.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 1 (n=80, 41)
|
92.5 Percentage of participants
|
78 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 2 (n=78, 39)
|
91.0 Percentage of participants
|
87.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
84.6 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 3 (n=74, 38)
|
93.2 Percentage of participants
|
84.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 3 (n=73, 38)
|
100.0 Percentage of participants
|
84.2 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 1 (n=80, 41)
|
58.8 Percentage of participants
|
56.1 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 1 (n=80, 41)
|
87.5 Percentage of participants
|
63.4 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 2 (n=78, 39)
|
85.9 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 2 (n=78, 39)
|
100.0 Percentage of participants
|
71.8 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 3 (n=74, 38)
|
85.1 Percentage of participants
|
73.7 Percentage of participants
|
|
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 3 (n=73, 38)
|
98.6 Percentage of participants
|
78.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Seropositivity was assessed in the Full Analysis Set.
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=19 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=8 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 1 (n=19, 8)
|
94.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 2 (n=16, 8)
|
81.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 2 (n=16, 8)
|
100.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 3 (n=16, 8)
|
93.8 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 3 (n=16, 8)
|
100.0 Percentage of participants
|
25 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 1 (n=19, 8)
|
78.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 2 (n=16, 8)
|
68.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 2 (n=16, 8)
|
100.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 3 (n=16, 8)
|
68.8 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 3 (n=16, 8)
|
100.0 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 1 (n=19, 8)
|
36.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 2 (n=16, 8)
|
37.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 2 (n=16, 8)
|
93.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 3 (n=16, 8)
|
56.3 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 3 (n=16, 8)
|
93.8 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 1 (n=19, 8)
|
0.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 1 (n=19, 8)
|
10.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 2 (n=16, 8)
|
18.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 2 (n=16, 8)
|
75.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 3 (n=16, 8)
|
37.5 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 3 (n=16, 8)
|
87.5 Percentage of participants
|
12.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Geometric mean titer ratios were assessed in the Full Analysis Set.
Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=49 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)
|
6.50 Titer ratio
Interval 5.01 to 8.45
|
0.916 Titer ratio
Interval 0.673 to 1.25
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
|
8.57 Titer ratio
Interval 6.79 to 10.8
|
1.85 Titer ratio
Interval 1.03 to 3.32
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
|
2.03 Titer ratio
Interval 1.58 to 2.61
|
1.02 Titer ratio
Interval 0.701 to 1.47
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
|
6.26 Titer ratio
Interval 4.82 to 8.13
|
1.24 Titer ratio
Interval 0.815 to 1.9
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)
|
4.67 Titer ratio
Interval 3.37 to 6.47
|
0.834 Titer ratio
Interval 0.699 to 0.994
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
|
7.26 Titer ratio
Interval 5.51 to 9.57
|
2.11 Titer ratio
Interval 1.12 to 4.0
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
|
1.66 Titer ratio
Interval 1.31 to 2.1
|
1.25 Titer ratio
Interval 0.801 to 1.94
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
|
4.92 Titer ratio
Interval 3.71 to 6.52
|
1.36 Titer ratio
Interval 0.797 to 2.31
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
|
1.07 Titer ratio
Interval 0.828 to 1.39
|
0.793 Titer ratio
Interval 0.508 to 1.24
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post -nj. 3 / Pre-Inj. 3 (n=89, 46)
|
1.48 Titer ratio
Interval 1.25 to 1.74
|
0.706 Titer ratio
Interval 0.607 to 0.821
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)
|
4.15 Titer ratio
Interval 3.07 to 5.59
|
0.733 Titer ratio
Interval 0.639 to 0.84
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
|
6.80 Titer ratio
Interval 5.46 to 8.45
|
1.75 Titer ratio
Interval 0.956 to 3.21
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
|
1.97 Titer ratio
Interval 1.56 to 2.5
|
0.981 Titer ratio
Interval 0.66 to 1.46
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
|
6.21 Titer ratio
Interval 4.96 to 7.78
|
1.68 Titer ratio
Interval 1.06 to 2.66
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
|
1.78 Titer ratio
Interval 1.39 to 2.28
|
0.944 Titer ratio
Interval 0.646 to 1.38
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 3 / Pre-Inj. 3 (n=89, 46)
|
1.40 Titer ratio
Interval 1.16 to 1.69
|
0.851 Titer ratio
Interval 0.734 to 0.986
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
|
1.46 Titer ratio
Interval 1.11 to 1.91
|
0.673 Titer ratio
Interval 0.489 to 0.925
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46)
|
1.53 Titer ratio
Interval 1.27 to 1.86
|
0.8 Titer ratio
Interval 0.681 to 0.94
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48)
|
17.7 Titer ratio
Interval 12.1 to 26.0
|
0.806 Titer ratio
Interval 0.665 to 0.976
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
|
15.4 Titer ratio
Interval 12.3 to 19.2
|
1.27 Titer ratio
Interval 0.795 to 2.04
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
|
1.84 Titer ratio
Interval 1.5 to 2.26
|
0.835 Titer ratio
Interval 0.587 to 1.19
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
|
20.2 Titer ratio
Interval 15.4 to 26.3
|
1.4 Titer ratio
Interval 0.939 to 2.1
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
|
2.26 Titer ratio
Interval 1.74 to 2.93
|
0.912 Titer ratio
Interval 0.606 to 1.37
|
|
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post -nj. 3 / Pre-Inj. 3 (n=87, 46)
|
1.68 Titer ratio
Interval 1.38 to 2.05
|
0.723 Titer ratio
Interval 0.564 to 0.927
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Geometric mean titers were assessed in the Full Analysis Set.
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=49 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2 (n=94, 47)
|
346 Titers (1/dilutions)
Interval 281.0 to 425.0
|
31.2 Titers (1/dilutions)
Interval 18.1 to 53.7
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 3 (n=88, 46)
|
258 Titers (1/dilutions)
Interval 192.0 to 347.0
|
37.4 Titers (1/dilutions)
Interval 22.6 to 62.1
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3 (n=89, 46)
|
432 Titers (1/dilutions)
Interval 335.0 to 556.0
|
33.4 Titers (1/dilutions)
Interval 21.5 to 51.9
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 1 (n=99, 49)
|
256 Titers (1/dilutions)
Interval 151.0 to 433.0
|
50.7 Titers (1/dilutions)
Interval 29.5 to 87.3
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 2 (n=94, 47)
|
230 Titers (1/dilutions)
Interval 138.0 to 384.0
|
86 Titers (1/dilutions)
Interval 43.8 to 169.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2 (n=94, 47)
|
436 Titers (1/dilutions)
Interval 287.0 to 662.0
|
130 Titers (1/dilutions)
Interval 59.7 to 283.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 3 (n=90, 46)
|
162 Titers (1/dilutions)
Interval 99.8 to 262.0
|
90.8 Titers (1/dilutions)
Interval 46.6 to 177.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3 (n=89, 46)
|
267 Titers (1/dilutions)
Interval 181.0 to 394.0
|
79.2 Titers (1/dilutions)
Interval 42.4 to 148.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1 (n=99, 49)
|
67.0 Titers (1/dilutions)
Interval 44.0 to 102.0
|
68.3 Titers (1/dilutions)
Interval 36.3 to 129.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 1 (n=99, 49)
|
352 Titers (1/dilutions)
Interval 210.0 to 592.0
|
62.8 Titers (1/dilutions)
Interval 33.9 to 116.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 2 (n=94, 47)
|
287 Titers (1/dilutions)
Interval 173.0 to 475.0
|
117 Titers (1/dilutions)
Interval 57.6 to 238.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2 (n=94, 47)
|
647 Titers (1/dilutions)
Interval 449.0 to 932.0
|
137 Titers (1/dilutions)
Interval 61.4 to 306.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 3 (n=90, 46)
|
360 Titers (1/dilutions)
Interval 219.0 to 592.0
|
131 Titers (1/dilutions)
Interval 65.7 to 262.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3 (n=89, 46)
|
544 Titers (1/dilutions)
Interval 378.0 to 782.0
|
132 Titers (1/dilutions)
Interval 67.0 to 259.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1 (n=99, 49)
|
81.9 Titers (1/dilutions)
Interval 49.3 to 136.0
|
94.7 Titers (1/dilutions)
Interval 43.6 to 206.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 1 (n=99, 49)
|
690 Titers (1/dilutions)
Interval 423.0 to 1125.0
|
110 Titers (1/dilutions)
Interval 50.3 to 242.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 2 (n=94, 47)
|
471 Titers (1/dilutions)
Interval 282.0 to 787.0
|
184 Titers (1/dilutions)
Interval 80.3 to 424.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2 (n=94, 47)
|
1031 Titers (1/dilutions)
Interval 704.0 to 1512.0
|
227 Titers (1/dilutions)
Interval 92.8 to 556.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 3 (n=89, 46)
|
481 Titers (1/dilutions)
Interval 300.0 to 772.0
|
144 Titers (1/dilutions)
Interval 65.8 to 316.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3 (n=89, 46)
|
741 Titers (1/dilutions)
Interval 516.0 to 1062.0
|
140 Titers (1/dilutions)
Interval 66.0 to 298.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1 (n=99, 49)
|
15.0 Titers (1/dilutions)
Interval 11.6 to 19.4
|
17.5 Titers (1/dilutions)
Interval 11.9 to 25.8
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 1 (n=99, 48)
|
383 Titers (1/dilutions)
Interval 262.0 to 559.0
|
19.2 Titers (1/dilutions)
Interval 13.3 to 27.7
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 2 (n=94, 47)
|
178 Titers (1/dilutions)
Interval 134.0 to 238.0
|
27.8 Titers (1/dilutions)
Interval 16.9 to 45.8
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1 (n=99, 49)
|
41.4 Titers (1/dilutions)
Interval 27.7 to 62.1
|
47.2 Titers (1/dilutions)
Interval 26.9 to 82.7
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Geometric mean titers were assessed in the Full Analysis Set.
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=80 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=41 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1 (n=80, 41)
|
68.5 Titers (1/dilutions)
Interval 44.5 to 105.0
|
73.1 Titers (1/dilutions)
Interval 40.9 to 131.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 1 (n=80, 41)
|
549 Titers (1/dilutions)
Interval 328.0 to 918.0
|
79.8 Titers (1/dilutions)
Interval 46.1 to 138.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 2 (n=78, 39)
|
430 Titers (1/dilutions)
Interval 261.0 to 709.0
|
154 Titers (1/dilutions)
Interval 78.5 to 303.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2 (n=78, 39)
|
661 Titers (1/dilutions)
Interval 442.0 to 987.0
|
253 Titers (1/dilutions)
Interval 116.0 to 553.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 3 (n=74, 38)
|
268 Titers (1/dilutions)
Interval 164.0 to 435.0
|
143 Titers (1/dilutions)
Interval 73.7 to 278.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3 (n=73, 38)
|
381 Titers (1/dilutions)
Interval 256.0 to 566.0
|
126 Titers (1/dilutions)
Interval 67.6 to 236.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1 (n=80, 41)
|
124 Titers (1/dilutions)
Interval 81.9 to 188.0
|
114 Titers (1/dilutions)
Interval 59.7 to 217.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 1 (n=80, 40)
|
467 Titers (1/dilutions)
Interval 325.0 to 672.0
|
25.2 Titers (1/dilutions)
Interval 17.1 to 37.1
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 2 (n=78, 39)
|
220 Titers (1/dilutions)
Interval 164.0 to 295.0
|
39.5 Titers (1/dilutions)
Interval 23.1 to 67.6
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2 (n=78, 39)
|
377 Titers (1/dilutions)
Interval 303.0 to 470.0
|
45.3 Titers (1/dilutions)
Interval 25.1 to 81.8
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 3 (n=73, 38)
|
313 Titers (1/dilutions)
Interval 231.0 to 424.0
|
53.9 Titers (1/dilutions)
Interval 31.7 to 91.8
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 1 (n=80, 41)
|
816 Titers (1/dilutions)
Interval 517.0 to 1290.0
|
103 Titers (1/dilutions)
Interval 54.8 to 193.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 2 (n=78, 39)
|
591 Titers (1/dilutions)
Interval 376.0 to 928.0
|
224 Titers (1/dilutions)
Interval 112.0 to 446.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2 (n=78, 39)
|
978 Titers (1/dilutions)
Interval 697.0 to 1374.0
|
271 Titers (1/dilutions)
Interval 120.0 to 610.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 3 (n=74, 38)
|
648 Titers (1/dilutions)
Interval 400.0 to 1048.0
|
240 Titers (1/dilutions)
Interval 122.0 to 471.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3 (n=73, 38)
|
835 Titers (1/dilutions)
Interval 584.0 to 1193.0
|
242 Titers (1/dilutions)
Interval 126.0 to 463.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1 (n=80, 41)
|
159 Titers (1/dilutions)
Interval 93.5 to 271.0
|
168 Titers (1/dilutions)
Interval 74.3 to 380.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 1 (n=80, 41)
|
1263 Titers (1/dilutions)
Interval 764.0 to 2088.0
|
202 Titers (1/dilutions)
Interval 89.3 to 455.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 2 (n=78, 39)
|
879 Titers (1/dilutions)
Interval 531.0 to 1455.0
|
387 Titers (1/dilutions)
Interval 170.0 to 878.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2 (n=78, 39)
|
1426 Titers (1/dilutions)
Interval 950.0 to 2141.0
|
497 Titers (1/dilutions)
Interval 204.0 to 1210.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 3 (n=74, 38)
|
776 Titers (1/dilutions)
Interval 481.0 to 1251.0
|
272 Titers (1/dilutions)
Interval 122.0 to 606.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3 (n=73, 38)
|
1031 Titers (1/dilutions)
Interval 700.0 to 1519.0
|
266 Titers (1/dilutions)
Interval 125.0 to 566.0
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1 (n=80, 41)
|
19.5 Titers (1/dilutions)
Interval 14.6 to 26.1
|
22.4 Titers (1/dilutions)
Interval 14.6 to 34.3
|
|
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3 (n=73, 38)
|
485 Titers (1/dilutions)
Interval 374.0 to 628.0
|
46.5 Titers (1/dilutions)
Interval 29.3 to 73.6
|
PRIMARY outcome
Timeframe: Before and 28 days after each injectionPopulation: Geometric mean titer ratios were assessed in the Full Analysis Set.
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=19 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=8 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8)
|
2.55 Titer ratio
Interval 1.37 to 4.75
|
0.578 Titer ratio
Interval 0.401 to 0.832
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
|
1.03 Titer ratio
Interval 0.639 to 1.67
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
|
5.73 Titer ratio
Interval 1.89 to 17.3
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
|
3.25 Titer ratio
Interval 1.18 to 8.93
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
|
5.34 Titer ratio
Interval 2.25 to 12.7
|
0.861 Titer ratio
Interval 0.238 to 3.11
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
|
3.03 Titer ratio
Interval 1.35 to 6.8
|
0.861 Titer ratio
Interval 0.238 to 3.11
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj. 3 / Pre-Inj. 3 (n=16, 8)
|
2.19 Titer ratio
Interval 1.37 to 3.48
|
0.446 Titer ratio
Interval 0.342 to 0.584
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
|
1.02 Titer ratio
Interval 0.527 to 1.99
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
|
8.62 Titer ratio
Interval 3.49 to 21.3
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
|
6.02 Titer ratio
Interval 2.37 to 15.3
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
|
7.67 Titer ratio
Interval 4.19 to 14.0
|
0.737 Titer ratio
Interval 0.294 to 1.85
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
|
5.36 Titer ratio
Interval 2.73 to 10.5
|
0.737 Titer ratio
Interval 0.294 to 1.85
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post -nj. 3 / Pre-Inj. 3 (n=16, 8)
|
2.37 Titer ratio
Interval 1.35 to 4.17
|
0.538 Titer ratio
Interval 0.453 to 0.639
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
|
5.41 Titer ratio
Interval 2.8 to 10.5
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
|
21.2 Titer ratio
Interval 10.5 to 42.9
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
|
7.58 Titer ratio
Interval 3.12 to 18.4
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
|
16.3 Titer ratio
Interval 9.65 to 27.7
|
0.678 Titer ratio
Interval 0.33 to 1.39
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
|
5.83 Titer ratio
Interval 3.17 to 10.7
|
0.678 Titer ratio
Interval 0.33 to 1.39
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8)
|
3.35 Titer ratio
Interval 1.92 to 5.84
|
0.524 Titer ratio
Interval 0.469 to 0.587
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
|
16.5 Titer ratio
Interval 4.58 to 59.1
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
|
22.7 Titer ratio
Interval 12.8 to 40.3
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
|
3.15 Titer ratio
Interval 1.63 to 6.09
|
0.5 Titer ratio
Interval 0.5 to 0.5
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
|
25.5 Titer ratio
Interval 11.6 to 55.9
|
0.701 Titer ratio
Interval 0.414 to 1.19
|
|
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
|
3.53 Titer ratio
Interval 1.71 to 7.26
|
0.701 Titer ratio
Interval 0.414 to 1.19
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post each vaccinationPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=50 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Injection-site Pain; Post-Any Injection (N=100,49)
|
40 Percentage of participants
|
40.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj.-site Pain; Post-Any Inj. (N=100,49)
|
0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Erythema; Post-Any Inj. (N=100,49)
|
4.0 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Erythema; Post-Any Inj. (N=100,49)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Swelling; Post-Any Inj. (N=100,49)
|
5.0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Swelling; Post-Any Inj. (N=100,49)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Injection-site Pain; Post-Injection 1 (N=99,49)
|
26.3 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Pain; Post-Inj. 1 (N=99,49)
|
0 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Erythema; Post-Inj. 1 (N=99,49)
|
1.0 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Erythema; Post-Inj. 1 (N=99,49)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Swelling; Post-Inj. 1 (N=99,49)
|
2.0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Swelling; Post-Inj. 1 (N=99,49)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Injection-site Pain; Post-Injection 2 (N=93,47)
|
21.5 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Pain; Post-Inj. 2 (N=93,47)
|
0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Erythema; Post-Inj. 2 (N=93,47)
|
3.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Erythema; Post-Inj. 2 (N=93,47)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Swelling; Post-Inj. 2 (N=93,47)
|
2.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Swelling; Post-Inj. 2 (N=93,47)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Injection-site Pain; Post-Injection 3 (N=89,45)
|
16.9 Percentage of participants
|
15.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Pain; Post-Inj. 3 (N=89,45)
|
0 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Erythema; Post-Inj. 3 (N=89,45)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Erythema; Post-Inj. 3 (N=89,45)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj.-site Swelling; Post-Inj. 3 (N=89,45)
|
1.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Gr 3 Inj.-site Swelling; Post-Inj. 3 (N=89,45)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Any Injection (N=100, 49)
|
30.0 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Any Injection (N=100, 49)
|
8.0 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Any Injection (N=100, 49)
|
61.0 Percentage of participants
|
51 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Any Injection (N=100, 49)
|
15.0 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Any Injection (N=100, 49)
|
40.0 Percentage of participants
|
32.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Any Injection (N=100, 49)
|
11.0 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Any Injection (N=100, 49)
|
42.0 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Any Injection (N=100, 49)
|
6.0 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Any Injection (N=100, 49)
|
35.0 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Any Injection (N=100, 49)
|
8.0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Injection 1 (N=98, 48)
|
15.3 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Injection 1 (N=98, 48)
|
3.1 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Injection 1 (N=99, 49)
|
48.5 Percentage of participants
|
40.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Injection 1 (N=99, 49)
|
8.1 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Injection 1 (N=99, 49)
|
31.3 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Injection 1 (N=99, 49)
|
3.0 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Injection 1 (N=99, 49)
|
32.3 Percentage of participants
|
30.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Injection 1 (N=99, 49)
|
2.0 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Injection 1 (N=99, 49)
|
22.2 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Injection 1 (N=99, 49)
|
4.0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Injection 2 (N=92, 47)
|
8.7 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Injection 2 (N=92, 47)
|
2.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Injection 2 (N=94, 47)
|
28.7 Percentage of participants
|
34 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Injection 2 (N=94, 47)
|
5.3 Percentage of participants
|
6.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Injection 2 (N=94, 47)
|
18.1 Percentage of participants
|
17 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Injection 2 (N=94, 47)
|
6.4 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Injection 2 (N=94, 47)
|
20.2 Percentage of participants
|
21.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Injection 2 (N=94, 47)
|
3.2 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Injection 2 (N=94, 47)
|
12.8 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Injection 2 (N=94, 47)
|
3.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Injection 3 (N=82, 43)
|
11.0 Percentage of participants
|
7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Injection 3 (N=82, 43)
|
3.7 Percentage of participants
|
7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Injection 3 (N=89, 45)
|
27.0 Percentage of participants
|
20 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Injection 3 (N=89, 45)
|
5.6 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Injection 3 (N=89, 45)
|
15.7 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Injection 3 (N=89, 45)
|
2.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Injection 3 (N=89, 45)
|
20.2 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Injection 3 (N=89, 45)
|
2.2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Injection 3 (N=89, 45)
|
14.6 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Injection 3 (N=89, 45)
|
2.2 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 5 serious events
Other events: 61 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=100 participants at risk
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=50 participants at risk
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/100 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Pregnancy, puerperium and perinatal conditions
Intra uterine death
|
1.0%
1/100 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
0.00%
0/50 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/100 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Gastrointestinal disorders
Food poisoning
|
1.0%
1/100 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
0.00%
0/50 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Abdominal wall abscess
|
1.0%
1/100 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
0.00%
0/50 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Appendicitis
|
1.0%
1/100 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Cellulitis
|
2.0%
2/100 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
0.00%
0/50 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/100 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=100 participants at risk
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Control Group
n=50 participants at risk
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
6.0%
6/100 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
8.0%
4/50 • Number of events 4 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/100 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
6/100 • Number of events 7 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
8.0%
4/50 • Number of events 4 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.0%
9/100 • Number of events 9 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
2.0%
1/50 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Nervous system disorders
Headache: Post Any Injection
|
61.0%
61/100 • Number of events 61 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
51.0%
25/49 • Number of events 25 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Eye disorders
Conjunctivitis
|
11.0%
11/100 • Number of events 11 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
14.0%
7/50 • Number of events 7 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
General disorders
Injection site Pain; Post Any Injection
|
40.0%
40/100 • Number of events 40 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
40.8%
20/49 • Number of events 20 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
General disorders
Injection site Swelling; Post Any Injection
|
5.0%
5/100 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
4.1%
2/49 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
General disorders
Fever; Post Any Injection
|
30.0%
30/100 • Number of events 30 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
18.4%
9/49 • Number of events 9 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
General disorders
Malaise; Post-Any Injection
|
40.0%
40/100 • Number of events 40 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
32.7%
16/49 • Number of events 16 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
General disorders
Asthenia; Post-Any Injection
|
35.0%
35/100 • Number of events 35 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
20.4%
10/49 • Number of events 10 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
12/100 • Number of events 16 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
8.0%
4/50 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Gastrointestinal disorders
Nausea
|
8.0%
8/100 • Number of events 11 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
0.00%
0/50 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
7/100 • Number of events 7 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
4.0%
2/50 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia; Post-Any Injection
|
42.0%
42/100 • Number of events 42 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
42.9%
21/49 • Number of events 21 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Nasopharyngitis
|
12.0%
12/100 • Number of events 12 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
12.0%
6/50 • Number of events 6 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Rhinitis
|
6.0%
6/100 • Number of events 7 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
4.0%
2/50 • Number of events 2 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Tonsillitis
|
5.0%
5/100 • Number of events 5 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
0.00%
0/50 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
|
Infections and infestations
Upper respiratory tract infection
|
18.0%
18/100 • Number of events 19 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER