Trial Outcomes & Findings for Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America (NCT NCT00993447)
NCT ID: NCT00993447
Last Updated: 2022-03-24
Results Overview
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
600 participants
Primary outcome timeframe
Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Results posted on
2022-03-24
Participant Flow
Study participants were enrolled from 09 October 2009 to 25 February 2010 in 3 clinic centers in Colombia, 1 in Honduras, 3 in Mexico, and 1 in Puerto Rico.
A total of 600 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Dengue Vaccine Group
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Overall Study
STARTED
|
401
|
199
|
|
Overall Study
COMPLETED
|
364
|
180
|
|
Overall Study
NOT COMPLETED
|
37
|
19
|
Reasons for withdrawal
| Measure |
Dengue Vaccine Group
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
8
|
|
Overall Study
Protocol Violation
|
12
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Baseline characteristics by cohort
| Measure |
Dengue Vaccine Group
n=401 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
401 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
600 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
|
12.6 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
12.5 Years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
12.55 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
105 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Region of Enrollment
Honduras
|
106 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
119 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
71 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-each vaccination) and Day 28 post-each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
Dengue Vaccine Group
n=401 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 1 (N=379,191)
|
63.1 Percentage of participants
|
68.1 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 1 (N=379,191)
|
64.9 Percentage of participants
|
68.1 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1 (N=379,191)
|
73.1 Percentage of participants
|
67.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 2 (N=353,174)
|
75.6 Percentage of participants
|
67.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2 (N=353,174)
|
85.0 Percentage of participants
|
69.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 3 (N=335,163)
|
79.7 Percentage of participants
|
73.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3 (N=335,163)
|
94.6 Percentage of participants
|
75.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 1 (N=379,191)
|
69.9 Percentage of participants
|
74.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1 (N=379,191)
|
85.2 Percentage of participants
|
72.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 2 (N=353,174)
|
87.3 Percentage of participants
|
71.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2 (N=353,174)
|
96.9 Percentage of participants
|
73.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 3 (N=335,163)
|
91.9 Percentage of participants
|
76.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3 (N=335,163)
|
99.1 Percentage of participants
|
78.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 1 (N=379,191)
|
69.9 Percentage of participants
|
73.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1 (N=379,191)
|
90.8 Percentage of participants
|
74.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 2 (N=353,174)
|
90.9 Percentage of participants
|
72.4 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2 (N=353,174)
|
98.6 Percentage of participants
|
73.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 3 (N=335,163)
|
96.4 Percentage of participants
|
74.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3 (N=335,163)
|
100.0 Percentage of participants
|
76.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1 (N=379,191)
|
92.6 Percentage of participants
|
62.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 2 (N=353,174)
|
92.4 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2 (N=353,174)
|
96.6 Percentage of participants
|
70.1 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 3 (N=335,163)
|
95.8 Percentage of participants
|
69.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3 (N=335,163)
|
98.8 Percentage of participants
|
69.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-each vaccination) and Day 28 post-each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.
Outcome measures
| Measure |
Dengue Vaccine Group
n=316 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=160 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2 (N=293,147)
|
98.6 Percentage of Participants
|
90.5 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 3 (N=288,143)
|
96.5 Percentage of Participants
|
90.9 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3 (N=287,143)
|
99.7 Percentage of Participants
|
92.3 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 1 (N=316,160)
|
88.3 Percentage of Participants
|
90.6 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1 (N=305,158)
|
96.7 Percentage of Participants
|
89.9 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 2 (N=295,148)
|
96.6 Percentage of Participants
|
87.8 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2 (N=293,147)
|
99.0 Percentage of Participants
|
88.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 3 (N=288,143)
|
97.9 Percentage of Participants
|
89.5 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3 (N=287,143)
|
100.0 Percentage of Participants
|
89.5 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 1 (N=316,160)
|
79.4 Percentage of Participants
|
84.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1 (N=305,158)
|
97.4 Percentage of Participants
|
76.6 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 2 (N=295,148)
|
96.9 Percentage of Participants
|
81.1 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2 (N=293,147)
|
98.0 Percentage of Participants
|
84.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 3 (N=288,143)
|
99.3 Percentage of Participants
|
84.6 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3 (N=287,143)
|
100.0 Percentage of Participants
|
84.6 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 1 (N=316,160)
|
81.3 Percentage of Participants
|
84.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1 (N=305,158)
|
90.8 Percentage of Participants
|
82.3 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 2 (N=295,148)
|
90.5 Percentage of Participants
|
82.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2 (N=293,147)
|
95.6 Percentage of Participants
|
84.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 3 (N=288,143)
|
92.0 Percentage of Participants
|
87.4 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3 (N=287,143)
|
97.6 Percentage of Participants
|
88.8 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 1 (N=316,160)
|
88.0 Percentage of Participants
|
91.9 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1 (N=305,158)
|
96.4 Percentage of Participants
|
89.9 Percentage of Participants
|
|
Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 2 (N=295,148)
|
96.6 Percentage of Participants
|
89.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-each vaccination) and Day 28 post-each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.
Outcome measures
| Measure |
Dengue Vaccine Group
n=85 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=38 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 1 (N=85,38)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1 (N=84,37)
|
7.1 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 2 (N=78,36)
|
17.9 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2 (N=78,36)
|
44.9 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 3 (N=77,36)
|
33.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3 (N=77,36)
|
81.8 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 1 (N=85,38)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1 (N=84,37)
|
42.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 2 (N=78,36)
|
51.3 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2 (N=78,36)
|
89.7 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 3 (N=77,36)
|
70.1 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3 (N=77,36)
|
96.1 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 1 (N=85,38)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1 (N=84,37)
|
67.9 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 2 (N=78,36)
|
66.7 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2 (N=78,36)
|
94.9 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 3 (N=77,36)
|
89.6 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3 (N=77,36)
|
100.0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 1 (N=85,38)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1 (N=84,37)
|
73.8 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 2 (N=78,36)
|
73.1 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2 (N=78,36)
|
91.0 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 3 (N=77,36)
|
80.5 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3 (N=77,36)
|
94.8 Percentage of participants
|
5.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (before each vaccination) and Day 28 post each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
Dengue Vaccine Group
n=401 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)
|
75.1 Percentage of participants
|
77.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 1 (N=389,196)
|
98.2 Percentage of participants
|
78.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj. 2 (N=373,185)
|
99.2 Percentage of participants
|
76.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 2 (N=371,184)
|
99.7 Percentage of participants
|
76.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj. 3 (N=365,180)
|
100.0 Percentage of participants
|
79.4 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 3 (N=364,180)
|
100.0 Percentage of participants
|
78.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 1 (N=401,199)
|
69.1 Percentage of participants
|
72.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 1 (N=389,196)
|
91.0 Percentage of participants
|
70.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 2 (N=373,185)
|
91.4 Percentage of participants
|
71.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 2 (N=371,184)
|
98.9 Percentage of participants
|
71.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 3 (N=365,180)
|
96.2 Percentage of participants
|
75.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 3 (N=364,180)
|
100.0 Percentage of participants
|
76.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 1 (N=401,199)
|
64.6 Percentage of participants
|
69.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 1 (N=381,196)
|
79.9 Percentage of participants
|
67.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 2 (N=373,185)
|
81.8 Percentage of participants
|
68.1 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 2 (N=371,184)
|
94.3 Percentage of participants
|
69.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 3 (N=365,180)
|
88.2 Percentage of participants
|
70.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 3 (N=364,180)
|
98.6 Percentage of participants
|
72.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 1 (N=401,199)
|
56.9 Percentage of participants
|
61.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 1 (N=389,196)
|
71.2 Percentage of participants
|
59.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 2 (N=373,185)
|
72.4 Percentage of participants
|
60.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 2 (N=371,184)
|
83.3 Percentage of participants
|
66.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 3 (N=365,180)
|
77.8 Percentage of participants
|
64.4 Percentage of participants
|
|
Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 3 (N=364,180)
|
93.4 Percentage of participants
|
66.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (before each vaccination) and Day 28 post each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
Dengue Vaccine Group
n=316 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=160 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)
|
95.3 Percentage of participants
|
96.9 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 1 (N=389,196)
|
99.0 Percentage of participants
|
93.7 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj. 2 (N=373,185)
|
99.7 Percentage of participants
|
91.9 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 2 (N=371,184)
|
99.7 Percentage of participants
|
93.2 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj. 3 (N=365,180)
|
100.0 Percentage of participants
|
93.7 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 3 (N=364,180)
|
100.0 Percentage of participants
|
93.0 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 1 (N=401,199)
|
87.7 Percentage of participants
|
90.6 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 1 (N=389,196)
|
97.4 Percentage of participants
|
88.0 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 2 (N=373,185)
|
97.3 Percentage of participants
|
89.2 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 2 (N=371,184)
|
99.0 Percentage of participants
|
87.8 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 3 (N=365,180)
|
98.6 Percentage of participants
|
91.6 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 3 (N=364,180)
|
100.0 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 1 (N=401,199)
|
92.0 Percentage of participants
|
86.9 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 1 (N=381,196)
|
95.1 Percentage of participants
|
83.5 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 2 (N=373,185)
|
94.2 Percentage of participants
|
84.5 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 2 (N=371,184)
|
98.3 Percentage of participants
|
85.0 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 3 (N=365,180)
|
96.2 Percentage of participants
|
86.7 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 3 (N=364,180)
|
99.7 Percentage of participants
|
87.4 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 1 (N=401,199)
|
72.2 Percentage of participants
|
76.9 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 1 (N=389,196)
|
89.8 Percentage of participants
|
73.4 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 2 (N=373,185)
|
89.5 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 2 (N=371,184)
|
94.2 Percentage of participants
|
81.6 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 3 (N=365,180)
|
91.0 Percentage of participants
|
80.4 Percentage of participants
|
|
Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 3 (N=364,180)
|
97.6 Percentage of participants
|
82.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (before each vaccination) and Day 28 post each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
Dengue Vaccine Group
n=85 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=38 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 1 (N=389,196)
|
95.0 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj. 2 (N=373,185)
|
97.4 Percentage of participants
|
13.9 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 2 (N=371,184)
|
100.0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Pre-inj. 3 (N=365,180)
|
100.0 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 1 Serotype; Post-inj. 3 (N=364,180)
|
100.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 1 (N=401,199)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 1 (N=389,196)
|
67.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 2 (N=373,185)
|
69.2 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 2 (N=371,184)
|
98.7 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Pre-inj. 3 (N=365,180)
|
87.0 Percentage of participants
|
13.9 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 2 Serotypes; Post-inj. 3 (N=364,180)
|
100.0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 1 (N=401,199)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 1 (N=381,196)
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 2 (N=373,185)
|
34.6 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 2 (N=371,184)
|
79.5 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Pre-inj. 3 (N=365,180)
|
58.4 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
At Least 3 Serotypes; Post-inj. 3 (N=364,180)
|
94.8 Percentage of participants
|
13.9 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 1 (N=401,199)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 1 (N=389,196)
|
3.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 2 (N=373,185)
|
7.7 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 2 (N=371,184)
|
42.3 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Pre-inj. 3 (N=365,180)
|
28.6 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
All 4 Serotypes; Post-inj. 3 (N=364,180)
|
77.9 Percentage of participants
|
5.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (before each vaccination) and Day 28 post-each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
Dengue Vaccine Group
n=401 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 1 (N=401,199)
|
74.2 Titers (1/dilution)
Interval 58.8 to 93.6
|
81.9 Titers (1/dilution)
Interval 59.2 to 113.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1 (N=389,196)
|
221 Titers (1/dilution)
Interval 167.0 to 292.0
|
77.1 Titers (1/dilution)
Interval 55.8 to 106.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 2 (N=373,185)
|
193 Titers (1/dilution)
Interval 149.0 to 251.0
|
96.6 Titers (1/dilution)
Interval 67.1 to 139.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2 (N=371,184)
|
276 Titers (1/dilution)
Interval 215.0 to 355.0
|
102 Titers (1/dilution)
Interval 70.9 to 147.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 3 (N=365,180)
|
204 Titers (1/dilution)
Interval 159.0 to 262.0
|
113 Titers (1/dilution)
Interval 80.0 to 159.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3 (N=364,180)
|
320 Titers (1/dilution)
Interval 258.0 to 396.0
|
106 Titers (1/dilution)
Interval 75.4 to 149.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 1 (N=401,199)
|
92.6 Titers (1/dilution)
Interval 73.9 to 116.0
|
100 Titers (1/dilution)
Interval 73.5 to 136.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1 (N=389,196)
|
409 Titers (1/dilution)
Interval 320.0 to 524.0
|
90.4 Titers (1/dilution)
Interval 66.6 to 123.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 2 (N=373,185)
|
326 Titers (1/dilution)
Interval 260.0 to 408.0
|
117 Titers (1/dilution)
Interval 82.2 to 166.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2 (N=371,184)
|
504 Titers (1/dilution)
Interval 414.0 to 613.0
|
114 Titers (1/dilution)
Interval 80.8 to 160.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 3 (N=365,180)
|
300 Titers (1/dilution)
Interval 245.0 to 368.0
|
133 Titers (1/dilution)
Interval 95.6 to 186.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3 (N=364,180)
|
486 Titers (1/dilution)
Interval 414.0 to 572.0
|
133 Titers (1/dilution)
Interval 96.2 to 185.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 1 (N=401,199)
|
85.0 Titers (1/dilution)
Interval 68.1 to 106.0
|
88.8 Titers (1/dilution)
Interval 65.9 to 120.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1 (N=389,196)
|
442 Titers (1/dilution)
Interval 352.0 to 554.0
|
93.2 Titers (1/dilution)
Interval 69.1 to 126.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 2 (N=372,185)
|
301 Titers (1/dilution)
Interval 243.0 to 372.0
|
107 Titers (1/dilution)
Interval 77.0 to 149.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2 (N=371,184)
|
502 Titers (1/dilution)
Interval 421.0 to 599.0
|
108 Titers (1/dilution)
Interval 76.8 to 151.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 3 (N=365,180)
|
379 Titers (1/dilution)
Interval 313.0 to 458.0
|
123 Titers (1/dilution)
Interval 87.3 to 172.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3 (N=364,180)
|
594 Titers (1/dilution)
Interval 511.0 to 692.0
|
121 Titers (1/dilution)
Interval 86.6 to 168.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 1 (N=401,199)
|
37.2 Titers (1/dilution)
Interval 31.1 to 44.5
|
40.1 Titers (1/dilution)
Interval 31.2 to 51.5
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1 (N=389,196)
|
416 Titers (1/dilution)
Interval 347.0 to 498.0
|
34.1 Titers (1/dilution)
Interval 26.5 to 43.9
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 2 (N=373,185)
|
200 Titers (1/dilution)
Interval 171.0 to 233.0
|
43.8 Titers (1/dilution)
Interval 33.2 to 57.8
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2 (N=369,184)
|
305 Titers (1/dilution)
Interval 265.0 to 352.0
|
43.9 Titers (1/dilution)
Interval 33.5 to 57.5
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 3 (N=365,180)
|
182 Titers (1/dilution)
Interval 158.0 to 210.0
|
47.7 Titers (1/dilution)
Interval 36.4 to 62.6
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3 (N=364,180)
|
273 Titers (1/dilution)
Interval 241.0 to 309.0
|
42.8 Titers (1/dilution)
Interval 33.0 to 55.5
|
PRIMARY outcome
Timeframe: Day 0 (before each vaccination) and Day 28 post each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.
Outcome measures
| Measure |
Dengue Vaccine Group
n=401 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=389,196)
|
2.36 Titers
Interval 2.02 to 2.76
|
0.756 Titers
Interval 0.689 to 0.829
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=371,184)
|
2.74 Titers
Interval 2.33 to 3.21
|
1.02 Titers
Interval 0.82 to 1.27
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=371,184)
|
1.19 Titers
Interval 1.06 to 1.34
|
0.851 Titers
Interval 0.735 to 0.985
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=364,180)
|
3.16 Titers
Interval 2.73 to 3.66
|
1.03 Titers
Interval 0.834 to 1.27
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=364,180)
|
1.38 Titers
Interval 1.22 to 1.56
|
0.859 Titers
Interval 0.71 to 1.04
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=364,180)
|
1.35 Titers
Interval 1.25 to 1.46
|
0.777 Titers
Interval 0.699 to 0.862
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=389,196)
|
3.55 Titers
Interval 3.04 to 4.15
|
0.760 Titers
Interval 0.702 to 0.823
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=371,184)
|
4.09 Titers
Interval 3.49 to 4.8
|
0.983 Titers
Interval 0.805 to 1.2
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=371,184)
|
1.40 Titers
Interval 1.25 to 1.58
|
0.811 Titers
Interval 0.698 to 0.941
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=364,180)
|
3.97 Titers
Interval 3.39 to 4.64
|
1.16 Titers
Interval 0.955 to 1.41
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=364,180)
|
1.36 Titers
Interval 1.19 to 1.55
|
0.957 Titers
Interval 0.777 to 1.18
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=364,180)
|
1.51 Titers
Interval 1.38 to 1.64
|
0.844 Titers
Interval 0.77 to 0.926
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=389,196)
|
4.24 Titers
Interval 3.61 to 4.98
|
0.864 Titers
Interval 0.786 to 0.95
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=371,184)
|
4.52 Titers
Interval 3.88 to 5.26
|
1.04 Titers
Interval 0.852 to 1.28
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=370,184)
|
1.57 Titers
Interval 1.4 to 1.76
|
0.840 Titers
Interval 0.725 to 0.975
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=364,180)
|
5.27 Titers
Interval 4.55 to 6.1
|
1.15 Titers
Interval 0.96 to 1.39
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=363,180)
|
1.86 Titers
Interval 1.64 to 2.1
|
0.937 Titers
Interval 0.78 to 1.13
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=364,180)
|
1.52 Titers
Interval 1.41 to 1.63
|
0.815 Titers
Interval 0.743 to 0.895
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=389,196)
|
8.63 Titers
Interval 7.09 to 10.5
|
0.672 Titers
Interval 0.603 to 0.75
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=369,184)
|
6.14 Titers
Interval 5.22 to 7.21
|
0.887 Titers
Interval 0.725 to 1.09
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=369,184)
|
1.45 Titers
Interval 1.29 to 1.62
|
0.800 Titers
Interval 0.703 to 0.911
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=364,180)
|
5.47 Titers
Interval 4.72 to 6.34
|
0.871 Titers
Interval 0.72 to 1.05
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=364,180)
|
1.30 Titers
Interval 1.16 to 1.46
|
0.771 Titers
Interval 0.656 to 0.906
|
|
Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=364,180)
|
1.45 Titers
Interval 1.34 to 1.56
|
0.723 Titers
Interval 0.671 to 0.78
|
PRIMARY outcome
Timeframe: Day 0 (before each vaccination) and Day 28 post each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.
Outcome measures
| Measure |
Dengue Vaccine Group
n=316 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=160 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 1 (N=316,160)
|
153 Titers (1/dilution)
Interval 121.0 to 194.0
|
162 Titers (1/dilution)
Interval 117.0 to 224.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1 (N=305,158)
|
604 Titers (1/dilution)
Interval 468.0 to 780.0
|
148 Titers (1/dilution)
Interval 107.0 to 205.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 2 (N=295,148)
|
447 Titers (1/dilution)
Interval 352.0 to 567.0
|
192 Titers (1/dilution)
Interval 133.0 to 279.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2 (N=293,147)
|
607 Titers (1/dilution)
Interval 483.0 to 764.0
|
199 Titers (1/dilution)
Interval 138.0 to 287.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 3 (N=288,143)
|
435 Titers (1/dilution)
Interval 344.0 to 550.0
|
225 Titers (1/dilution)
Interval 161.0 to 315.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3 (N=287,143)
|
580 Titers (1/dilution)
Interval 471.0 to 715.0
|
205 Titers (1/dilution)
Interval 146.0 to 287.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 1 (N=316,160)
|
203 Titers (1/dilution)
Interval 164.0 to 252.0
|
207 Titers (1/dilution)
Interval 156.0 to 275.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1 (N=305,158)
|
1001 Titers (1/dilution)
Interval 811.0 to 1236.0
|
181 Titers (1/dilution)
Interval 136.0 to 242.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 2 (N=295,148)
|
673 Titers (1/dilution)
Interval 555.0 to 817.0
|
251 Titers (1/dilution)
Interval 179.0 to 351.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2 (N=293,147)
|
888 Titers (1/dilution)
Interval 738.0 to 1067.0
|
232 Titers (1/dilution)
Interval 167.0 to 321.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 3 (N=288,143)
|
554 Titers (1/dilution)
Interval 461.0 to 667.0
|
265 Titers (1/dilution)
Interval 195.0 to 361.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3 (N=287,143)
|
741 Titers (1/dilution)
Interval 631.0 to 869.0
|
266 Titers (1/dilution)
Interval 196.0 to 359.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 1 (N=316,160)
|
182 Titers (1/dilution)
Interval 147.0 to 225.0
|
179 Titers (1/dilution)
Interval 136.0 to 237.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1 (N=305,158)
|
863 Titers (1/dilution)
Interval 700.0 to 1064.0
|
180 Titers (1/dilution)
Interval 135.0 to 239.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 2 (N=295,148)
|
556 Titers (1/dilution)
Interval 456.0 to 679.0
|
221 Titers (1/dilution)
Interval 161.0 to 304.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2 (N=293,147)
|
782 Titers (1/dilution)
Interval 654.0 to 936.0
|
215 Titers (1/dilution)
Interval 155.0 to 297.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 3 (N=288,143)
|
615 Titers (1/dilution)
Interval 510.0 to 743.0
|
265 Titers (1/dilution)
Interval 193.0 to 362.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3 (N=287,143)
|
827 Titers (1/dilution)
Interval 704.0 to 972.0
|
248 Titers (1/dilution)
Interval 181.0 to 340.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 1 (N=316,160)
|
63.8 Titers (1/dilution)
Interval 52.9 to 76.9
|
66.5 Titers (1/dilution)
Interval 51.4 to 86.1
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1 (N=305,158)
|
549 Titers (1/dilution)
Interval 465.0 to 649.0
|
53.4 Titers (1/dilution)
Interval 40.8 to 69.8
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 2 (N=295,148)
|
278 Titers (1/dilution)
Interval 239.0 to 322.0
|
73.7 Titers (1/dilution)
Interval 55.2 to 98.5
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2 (N=291,147)
|
395 Titers (1/dilution)
Interval 341.0 to 456.0
|
70.4 Titers (1/dilution)
Interval 53.3 to 92.8
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 3 (N=288,143)
|
259 Titers (1/dilution)
Interval 227.0 to 296.0
|
81.8 Titers (1/dilution)
Interval 62.1 to 108.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3 (N=287,143)
|
341 Titers (1/dilution)
Interval 299.0 to 388.0
|
72.5 Titers (1/dilution)
Interval 55.8 to 94.2
|
PRIMARY outcome
Timeframe: Day 0 (pre each vaccination) and Day 28 post each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.
Outcome measures
| Measure |
Dengue Vaccine Group
n=316 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=160 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=305,158)
|
3.49 Titers
Interval 2.94 to 4.15
|
0.829 Titers
Interval 0.743 to 0.924
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=293,147)
|
3.25 Titers
Interval 2.73 to 3.88
|
1.11 Titers
Interval 0.875 to 1.41
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=293,147)
|
1.25 Titers
Interval 1.1 to 1.43
|
0.925 Titers
Interval 0.793 to 1.08
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=287,143)
|
3.08 Titers
Interval 2.61 to 3.64
|
1.09 Titers
Interval 0.857 to 1.39
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=287,143)
|
1.19 Titers
Interval 1.05 to 1.35
|
0.907 Titers
Interval 0.723 to 1.14
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=287,143)
|
1.24 Titers
Interval 1.15 to 1.34
|
0.834 Titers
Interval 0.736 to 0.946
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=305,158)
|
4.43 Titers
Interval 3.74 to 5.24
|
0.840 Titers
Interval 0.766 to 0.921
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=293,147)
|
3.70 Titers
Interval 3.08 to 4.44
|
1.08 Titers
Interval 0.863 to 1.35
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=293,147)
|
1.27 Titers
Interval 1.12 to 1.44
|
0.865 Titers
Interval 0.735 to 1.02
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=287,143)
|
3.08 Titers
Interval 2.59 to 3.67
|
1.23 Titers
Interval 0.993 to 1.53
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=287,143)
|
1.06 Titers
Interval 0.939 to 1.2
|
0.982 Titers
Interval 0.775 to 1.25
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=287,143)
|
1.29 Titers
Interval 1.18 to 1.4
|
0.940 Titers
Interval 0.846 to 1.04
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=305,158)
|
4.35 Titers
Interval 3.67 to 5.15
|
0.941 Titers
Interval 0.85 to 1.04
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=293,147)
|
3.71 Titers
Interval 3.13 to 4.39
|
1.16 Titers
Interval 0.921 to 1.45
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=293,147)
|
1.36 Titers
Interval 1.2 to 1.55
|
0.906 Titers
Interval 0.779 to 1.05
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=287,143)
|
3.82 Titers
Interval 3.27 to 4.47
|
1.29 Titers
Interval 1.05 to 1.6
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=287,143)
|
1.43 Titers
Interval 1.27 to 1.62
|
1.03 Titers
Interval 0.824 to 1.28
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=287,143)
|
1.31 Titers
Interval 1.22 to 1.4
|
0.872 Titers
Interval 0.789 to 0.963
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=305,158)
|
7.40 Titers
Interval 6.03 to 9.08
|
0.712 Titers
Interval 0.625 to 0.812
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=291,147)
|
5.16 Titers
Interval 4.31 to 6.19
|
0.952 Titers
Interval 0.752 to 1.2
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=291,147)
|
1.39 Titers
Interval 1.22 to 1.57
|
0.847 Titers
Interval 0.739 to 0.971
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=287,143)
|
4.45 Titers
Interval 3.76 to 5.26
|
0.976 Titers
Interval 0.773 to 1.23
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=287,143)
|
1.20 Titers
Interval 1.06 to 1.36
|
0.849 Titers
Interval 0.698 to 1.03
|
|
Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=287,143)
|
1.30 Titers
Interval 1.21 to 1.4
|
0.796 Titers
Interval 0.73 to 0.868
|
PRIMARY outcome
Timeframe: Day 0 (pre-each vaccination) and Day 28 post-each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.
Outcome measures
| Measure |
Dengue Vaccine Group
n=85 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=38 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 3 (N=77,36)
|
30.3 Titers (1/dilution)
Interval 21.4 to 42.7
|
9.48 Titers (1/dilution)
Interval 5.6 to 16.1
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 1 (N=85,38)
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1 (N=84,37)
|
5.72 Titers (1/dilution)
Interval 5.1 to 6.42
|
5.15 Titers (1/dilution)
Interval 4.85 to 5.47
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 2 (N=78,36)
|
8.16 Titers (1/dilution)
Interval 5.98 to 11.1
|
6.18 Titers (1/dilution)
Interval 4.2 to 9.11
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2 (N=78,36)
|
14.3 Titers (1/dilution)
Interval 10.0 to 20.3
|
7.29 Titers (1/dilution)
Interval 4.27 to 12.5
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Pre-inj. 3 (N=77,36)
|
12.0 Titers (1/dilution)
Interval 8.48 to 16.9
|
7.93 Titers (1/dilution)
Interval 5.05 to 12.5
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3 (N=77,36)
|
34.6 Titers (1/dilution)
Interval 25.0 to 48.1
|
8.36 Titers (1/dilution)
Interval 5.31 to 13.2
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 1 (N=85,38)
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1 (N=84,37)
|
15.9 Titers (1/dilution)
Interval 11.4 to 22.3
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Pre-inj. 2 (N=78,36)
|
21.0 Titers (1/dilution)
Interval 14.2 to 31.1
|
5.50 Titers (1/dilution)
Interval 4.54 to 6.66
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2 (N=78,36)
|
60.0 Titers (1/dilution)
Interval 43.3 to 83.0
|
6.79 Titers (1/dilution)
Interval 4.37 to 10.6
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3 (N=77,36)
|
101 Titers (1/dilution)
Interval 77.2 to 133.0
|
9.45 Titers (1/dilution)
Interval 5.78 to 15.4
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 1 (N=85,38)
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1 (N=84,37)
|
38.8 Titers (1/dilution)
Interval 25.6 to 59.1
|
6.10 Titers (1/dilution)
Interval 4.89 to 7.6
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 2 (N=77,36)
|
28.6 Titers (1/dilution)
Interval 20.0 to 41.1
|
5.97 Titers (1/dilution)
Interval 4.75 to 7.5
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2 (N=78,36)
|
94.9 Titers (1/dilution)
Interval 70.7 to 127.0
|
7.07 Titers (1/dilution)
Interval 4.41 to 11.3
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Pre-inj. 3 (N=77,36)
|
61.9 Titers (1/dilution)
Interval 44.4 to 86.1
|
6.18 Titers (1/dilution)
Interval 4.58 to 8.34
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3 (N=77,36)
|
174 Titers (1/dilution)
Interval 136.0 to 221.0
|
7.53 Titers (1/dilution)
Interval 5.32 to 10.7
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 1 (N=85,38)
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1 (N=84,37)
|
151 Titers (1/dilution)
Interval 89.3 to 255.0
|
5.30 Titers (1/dilution)
Interval 4.71 to 5.96
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 2 (N=78,36)
|
57.5 Titers (1/dilution)
Interval 38.8 to 85.1
|
5.48 Titers (1/dilution)
Interval 4.8 to 6.26
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2 (N=78,36)
|
117 Titers (1/dilution)
Interval 84.8 to 161.0
|
6.77 Titers (1/dilution)
Interval 4.64 to 9.88
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Pre-inj. 3 (N=77,36)
|
48.3 Titers (1/dilution)
Interval 35.5 to 65.6
|
5.97 Titers (1/dilution)
Interval 4.87 to 7.32
|
|
Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3 (N=77,36)
|
119 Titers (1/dilution)
Interval 92.0 to 153.0
|
5.63 Titers (1/dilution)
Interval 4.76 to 6.65
|
PRIMARY outcome
Timeframe: Day 0 (pre-each vaccination) and Day 28 post-each vaccinationPopulation: Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.
Outcome measures
| Measure |
Dengue Vaccine Group
n=85 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=38 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=84,37)
|
0.572 Titers
Interval 0.51 to 0.642
|
0.515 Titers
Interval 0.485 to 0.547
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=78,36)
|
1.43 Titers
Interval 1.0 to 2.03
|
0.729 Titers
Interval 0.427 to 1.25
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=78,36)
|
0.990 Titers
Interval 0.773 to 1.27
|
0.613 Titers
Interval 0.41 to 0.917
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=77,36)
|
3.46 Titers
Interval 2.5 to 4.81
|
0.836 Titers
Interval 0.531 to 1.32
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=77,36)
|
2.39 Titers
Interval 1.78 to 3.22
|
0.703 Titers
Interval 0.512 to 0.964
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=77,36)
|
1.83 Titers
Interval 1.48 to 2.26
|
0.592 Titers
Interval 0.519 to 0.675
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=84,37)
|
1.59 Titers
Interval 1.14 to 2.23
|
0.500 Titers
Interval 0.5 to 0.5
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=78,36)
|
6.00 Titers
Interval 4.33 to 8.3
|
0.679 Titers
Interval 0.437 to 1.06
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=78,36)
|
2.04 Titers
Interval 1.5 to 2.77
|
0.630 Titers
Interval 0.431 to 0.921
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=77,36)
|
10.1 Titers
Interval 7.72 to 13.3
|
0.945 Titers
Interval 0.578 to 1.54
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=77,36)
|
3.40 Titers
Interval 2.35 to 4.91
|
0.876 Titers
Interval 0.55 to 1.4
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=77,36)
|
2.73 Titers
Interval 2.23 to 3.33
|
0.559 Titers
Interval 0.493 to 0.635
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=84,37)
|
3.88 Titers
Interval 2.56 to 5.91
|
0.610 Titers
Interval 0.489 to 0.76
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=78,36)
|
9.49 Titers
Interval 7.07 to 12.7
|
0.707 Titers
Interval 0.441 to 1.13
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=77,36)
|
2.67 Titers
Interval 2.13 to 3.35
|
0.627 Titers
Interval 0.402 to 0.977
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=77,36)
|
17.4 Titers
Interval 13.6 to 22.1
|
0.753 Titers
Interval 0.532 to 1.07
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=76,36)
|
4.90 Titers
Interval 3.68 to 6.53
|
0.668 Titers
Interval 0.498 to 0.896
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=77,36)
|
2.61 Titers
Interval 2.16 to 3.16
|
0.633 Titers
Interval 0.499 to 0.805
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=84,37)
|
15.1 Titers
Interval 8.93 to 25.5
|
0.530 Titers
Interval 0.471 to 0.596
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=78,36)
|
11.7 Titers
Interval 8.48 to 16.1
|
0.677 Titers
Interval 0.464 to 0.988
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=78,36)
|
1.69 Titers
Interval 1.31 to 2.17
|
0.642 Titers
Interval 0.445 to 0.925
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=77,36)
|
11.9 Titers
Interval 9.2 to 15.3
|
0.563 Titers
Interval 0.476 to 0.665
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=77,36)
|
1.75 Titers
Interval 1.31 to 2.34
|
0.533 Titers
Interval 0.441 to 0.645
|
|
Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=77,36)
|
2.15 Titers
Interval 1.74 to 2.64
|
0.499 Titers
Interval 0.46 to 0.541
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post-each vaccinationPopulation: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Outcome measures
| Measure |
Dengue Vaccine Group
n=401 Participants
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 Participants
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Pain (Any dose; N=392,198)
|
192 Participants
|
132 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Pain (Any dose; N=392,198)
|
13 Participants
|
7 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Erythema (Any dose; N=392,198)
|
26 Participants
|
18 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Erythema (Any dose; N=392,198)
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Swelling (Any dose; N=392,198)
|
20 Participants
|
16 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Swelling (Any dose; N=392,198)
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Pain (Post-dose 1; N=392,196)
|
121 Participants
|
54 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Pain (Post-dose 1; N=392,196)
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Erythema (Post-dose 1; N=390,196)
|
11 Participants
|
6 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Erythema (Post-dose 1; N=390,196)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Swelling (Post-dose 1; N=391,196)
|
8 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Swelling (Post-dose 1; N=391,196)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Pain (Post-dose 2; N=373,185)
|
101 Participants
|
31 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade Pain (Post-dose 2; N=373,185)
|
7 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Erythema (Post-dose 2; N=373,185)
|
12 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Erythema (Post-dose 2; N=373,185)
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Swelling (Post-dose 2; N=373,185)
|
8 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Swelling (Post-dose 2; N=373,185)
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Pain (Post-dose 3; N=364,180)
|
88 Participants
|
118 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Pain (Post-dose 3; N=364,180)
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Erythema (Post-dose 3; N=364,180)
|
8 Participants
|
16 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Erythema (Post-dose 3; N=364,180)
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Injection-site Swelling (Post-dose 3; N=364,180)
|
6 Participants
|
14 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Swelling (Post-dose 3; N=364,180)
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Fever (Any dose; N=392;197)
|
84 Participants
|
36 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Fever (Any dose; N=392;197)
|
13 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Headache (Any dose; N=391;198)
|
237 Participants
|
116 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Headache (Any dose; N=391;198)
|
40 Participants
|
11 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Malaise (Any dose; N=390;198)
|
157 Participants
|
82 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Malaise (Any dose; N=390;198)
|
21 Participants
|
8 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Myalgia (Any dose; N=390;198)
|
171 Participants
|
90 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Myalgia (Any dose; N=390;198)
|
22 Participants
|
10 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Asthenia (Any dose; N=390;198)
|
119 Participants
|
51 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Asthenia (Any dose; N=390;198)
|
14 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Fever (Post-dose 1; N=392;193)
|
43 Participants
|
13 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Fever (Post dose 1; N=392;193)
|
11 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Headache (Post-dose 1; N=391;197)
|
173 Participants
|
80 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Headache (Post-dose 1; N=391;197)
|
26 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Malaise (Post-dose 1; N=390;197)
|
102 Participants
|
45 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Malaise (Post-dose 1; N=390;197)
|
14 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Myalgia (Post-dose 1; N=390;197)
|
121 Participants
|
52 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Myalgia (Post-dose 1; N=390;197)
|
15 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Asthenia (Post-dose 1; N=390;197)
|
77 Participants
|
30 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Asthenia (Post dose 1; N=390;197)
|
7 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Fever (Post-dose 2; N=371;184)
|
29 Participants
|
16 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Fever (Post-dose 2; N=371;184)
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Headache (Post-dose 2; N=373;185)
|
131 Participants
|
69 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Headache (Post-dose 2; N=373;185)
|
14 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Malaise (Post-dose 2; N=373;185)
|
68 Participants
|
36 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Malaise (Post-dose 2; N=373;185)
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Myalgia (Post dose 2; N=373;185)
|
80 Participants
|
45 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Myalgia (Post-dose 2; N=373;185)
|
8 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Asthenia (Post-dose 2; N=373;185)
|
51 Participants
|
24 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Asthenia (Post-dose 2; N=373;185)
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Fever (Post-dose 3; N=362;180)
|
17 Participants
|
14 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Fever (Post-dose 3; N=362;180)
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Headache (Post-dose 3; N=364;180)
|
106 Participants
|
62 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Headache (Post-dose 3; N=364;180)
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Malaise (Post-dose 3; N=364;180)
|
60 Participants
|
41 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Malaise (Post-dose 3; N=364;180)
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Myalgia (Post-dose 3; N=364;180)
|
66 Participants
|
51 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Myalgia (Post-dose 3; N=364;180)
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Asthenia (Post-dose 3; N=364;180)
|
42 Participants
|
23 Participants
|
|
Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Grade 3 Asthenia (Post-dose 3; N=364;180)
|
2 Participants
|
2 Participants
|
Adverse Events
Dengue Vaccine Group
Serious events: 10 serious events
Other events: 237 other events
Deaths: 0 deaths
Control Group
Serious events: 15 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dengue Vaccine Group
n=401 participants at risk
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 participants at risk
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Appendicitis
|
0.75%
3/401 • Number of events 3 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
1.0%
2/199 • Number of events 2 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
1.0%
2/199 • Number of events 2 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Dengue fever
|
0.75%
3/401 • Number of events 3 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
1.5%
3/199 • Number of events 3 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/401 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.00%
0/199 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.25%
1/401 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.00%
0/199 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.25%
1/401 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.00%
0/199 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Nervous system disorders
Epilepsy
|
0.25%
1/401 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
0.00%
0/199 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Nervous system disorders
Migraine
|
0.00%
0/401 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
1.0%
2/199 • Number of events 2 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
Other adverse events
| Measure |
Dengue Vaccine Group
n=401 participants at risk
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
|
Control Group
n=199 participants at risk
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
17/401 • Number of events 19 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
6.0%
12/199 • Number of events 12 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
30/401 • Number of events 30 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
4.5%
9/199 • Number of events 10 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
26.2%
105/401 • Number of events 124 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
25.6%
51/199 • Number of events 61 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Nervous system disorders
Headache
|
60.6%
237/391 • Number of events 237 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
58.6%
116/198 • Number of events 116 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
24/401 • Number of events 26 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
11.6%
23/199 • Number of events 24 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.5%
14/401 • Number of events 16 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
5.0%
10/199 • Number of events 10 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
General disorders
Injection site Pain
|
49.0%
192/392 • Number of events 192 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
66.7%
132/198 • Number of events 132 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
General disorders
Injection site Erythema
|
6.6%
26/392 • Number of events 26 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
9.1%
18/198 • Number of events 18 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
General disorders
Injection site Swelling
|
5.1%
20/392 • Number of events 20 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
8.1%
16/198 • Number of events 16 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
General disorders
Fever
|
21.4%
84/392 • Number of events 84 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
18.3%
36/197 • Number of events 36 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
General disorders
Malaise
|
40.3%
157/390 • Number of events 157 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
41.4%
82/198 • Number of events 82 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
43.8%
171/390 • Number of events 171 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
45.5%
90/198 • Number of events 90 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
|
General disorders
Asthenia
|
30.5%
119/390 • Number of events 119 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
25.8%
51/198 • Number of events 51 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
|
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