Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01187433
Collaborator
(none)
150
1
2
28
5.4
Study Details
Study Description
Brief Summary
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.
Primary Objectives:
-
To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
-
To evaluate the safety of each vaccination with CYD dengue vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.
Study Design
Study Type:
Interventional
Actual Enrollment
:
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America
Study Start Date
:
Aug 1, 2010
Actual Primary Completion Date
:
Oct 1, 2012
Actual Study Completion Date
:
Dec 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dengue Vaccine Group Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine |
Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
0.5 mL, Subcutaneous (SC)
Other Names:
|
| Placebo Comparator: Control Group Participants will receive a placebo, NaCl 0.9%. |
Biological: NaCl 0.9%
0.5 mL, Subcutaneous
Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
0.5 mL, Intramuscular
Other Names:
Biological: Meningococcal A+C vaccine
0.5 mL, Intramuscular
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
- Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
- Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 Days after each injection]
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
- Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
- Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
- Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
- Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
- Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
- Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
- Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [Before and 28 days after each injection]
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
- Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo [Day 0 up to Day 14 post each vaccination]
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Eligibility Criteria
Criteria
Ages Eligible for Study:
9 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Aged 9 to 16 years on the day of inclusion
-
Participant in good health, based on medical history and physical examination
-
Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
-
Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
-
For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination
Exclusion Criteria :
-
Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
-
For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
-
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
-
Breast-feeding woman
-
Planned participation in another clinical trial during the present trial period
-
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
-
Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances
-
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
-
Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures
-
Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response
-
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
-
Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
-
Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
-
Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
-
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
-
Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vitória | Brazil | ES, 29040-091 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01187433
Other Study ID Numbers:
- CYD30
- UTN: U1111-1111-6073
First Posted:
Aug 24, 2010
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil. |
|---|---|
| Pre-assignment Detail | A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Period Title: Overall Study | ||
| STARTED | 100 | 50 |
| COMPLETED | 89 | 46 |
| NOT COMPLETED | 11 | 4 |
Baseline Characteristics
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. | Total of all reporting groups |
| Overall Participants | 100 | 50 | 150 |
| Age (Count of Participants) | |||
| <=18 years |
100
100%
|
50
100%
|
150
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | |||
| Age Continuous |
12.7
(2.1)
|
12.7
(2.2)
|
12.7
(2.15)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
59
59%
|
23
46%
|
82
54.7%
|
| Male |
41
41%
|
27
54%
|
68
45.3%
|
| Region of Enrollment (Number) [Number] | |||
| Brazil |
100
100%
|
50
100%
|
150
100%
|
Outcome Measures
| Title | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seropositivity was assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 99 | 49 |
| Serotype 1; Pre-Injection 1 (n=99, 49) |
59.6
59.6%
|
63.3
126.6%
|
| Serotype 1; Post-Injection 1 (n=99, 49) |
79.8
79.8%
|
69.4
138.8%
|
| Serotype 1; Pre-Injection 2 (n=94, 47) |
80.9
80.9%
|
72.3
144.6%
|
| Serotype 1; Post Injection 2 (n=94, 47) |
95.7
95.7%
|
72.3
144.6%
|
| Serotype 1; Pre-Injection 3 (n=90, 46) |
78.9
78.9%
|
69.6
139.2%
|
| Serotype 1; Post-Injection 3 (n=89, 46) |
96.6
96.6%
|
69.6
139.2%
|
| Serotype 2; Pre-Injection 1 (n=99, 49) |
65.7
65.7%
|
67.3
134.6%
|
| Serotype 2; Post-Injection 1 (n=99, 49) |
80.8
80.8%
|
67.3
134.6%
|
| Serotype 2; Pre-Injection 2 (n=94, 47) |
80.9
80.9%
|
74.5
149%
|
| Serotype 2; Post-Injection 2 (n=94, 47) |
98.9
98.9%
|
72.3
144.6%
|
| Serotype 2; Pre-Injection 3 (n=90, 46) |
85.6
85.6%
|
76.1
152.2%
|
| Serotype 2; Post-Injection 3 (n=89, 46) |
98.9
98.9%
|
76.1
152.2%
|
| Serotype 3; Pre-Injection 1 (n=99, 49) |
62.6
62.6%
|
65.3
130.6%
|
| Serotype 3; Post-Injection 1 (n=99, 49) |
92.9
92.9%
|
67.3
134.6%
|
| Serotype 3; Pre-Injection 2 (n=94, 47) |
89.4
89.4%
|
72.3
144.6%
|
| Serotype 3; Post-Injection 2 (n=94, 47) |
100.0
100%
|
72.3
144.6%
|
| Serotype 3; Pre-Injection 3 (n=89, 46) |
94.4
94.4%
|
71.7
143.4%
|
| Serotype 3; Post-Injection 3 (n=89, 46) |
100.0
100%
|
73.9
147.8%
|
| Serotype 4; Pre-Injection 1 (n=99, 49) |
47.5
47.5%
|
51
102%
|
| Serotype 4; Post -njection 1 (n=99, 48) |
89.9
89.9%
|
58.3
116.6%
|
| Serotype 4; Pre-Injection 2 (n=94, 47) |
92.6
92.6%
|
57.4
114.8%
|
| Serotype 4; Post-Injection 2 (n=94, 47) |
100.0
100%
|
59.6
119.2%
|
| Serotype 4; Pre-Injection 3 (n=88, 46) |
97.7
97.7%
|
69.6
139.2%
|
| Serotype 4; Post-Injection 3 (n=89, 46) |
100.0
100%
|
73.9
147.8%
|
| Title | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer. |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seropositivity was assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 80 | 41 |
| Serotype 1; Pre-Injection 1 (n=80, 41) |
73.8
73.8%
|
75.6
151.2%
|
| Serotype 1; Post-Injection 1 (n=80, 41) |
88.8
88.8%
|
82.9
165.8%
|
| Serotype 1; Pre-Injection 2 (n=78, 39) |
91.0
91%
|
87.2
174.4%
|
| Serotype 1; Post-Injection 2 (n=78, 39) |
100.0
100%
|
87.2
174.4%
|
| Serotype 1; Pre-Injection 3 (n=74, 38) |
87.8
87.8%
|
81.6
163.2%
|
| Serotype 1; Post-Injection 3 (n=73, 38) |
98.6
98.6%
|
81.6
163.2%
|
| Serotype 2; Pre-Injection 1 (n=80, 41) |
81.3
81.3%
|
80.5
161%
|
| Serotype 2; Post-Injection 1 (n=80, 41) |
93.8
93.8%
|
80.5
161%
|
| Serotype 2; Pre-Injection 2 (n=78, 39) |
92.3
92.3%
|
89.7
179.4%
|
| Serotype 2; Post-Injection 2 (n=78, 39) |
100.0
100%
|
87.2
174.4%
|
| Serotype 2; Pre-Injection 3 (n=74, 38) |
91.9
91.9%
|
89.5
179%
|
| Serotype 2; Post-Injection 3 (n=73, 38) |
100.0
100%
|
89.5
179%
|
| Serotype 3; Pre-Injection 1 (n=80, 41) |
77.5
77.5%
|
78
156%
|
| Serotype 3; Post-Injection 1 (n=80, 41) |
95.0
95%
|
80.5
161%
|
| Serotype 3; Pre-Injection 2 (n=78, 39) |
93.6
93.6%
|
87.2
174.4%
|
| Serotype 3; Post-Injection 2 (n=78, 39) |
100.0
100%
|
87.2
174.4%
|
| Serotype 3; Pre-Injection 3 (n=74, 38) |
97.3
97.3%
|
84.2
168.4%
|
| Serotype 3; Post-Injection 3 (n=73, 38) |
100.0
100%
|
86.8
173.6%
|
| Serotype 4; Pre-Injection 1 (n=80, 41) |
58.8
58.8%
|
61
122%
|
| Serotype 4; Post-Injection 1 (n=80, 40) |
95.0
95%
|
70
140%
|
| Serotype 4; Pre-Injection 2 (n=78, 39) |
94.9
94.9%
|
69.2
138.4%
|
| Serotype 4; Post-Injection 2 (n=78, 39) |
100.0
100%
|
71.8
143.6%
|
| Serotype 4; Pre-Injection 3 (n=73, 38) |
98.6
98.6%
|
81.6
163.2%
|
| Serotype 4; Post-Injection 3 (n=73, 38) |
100.0
100%
|
84.2
168.4%
|
| Title | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer. |
| Time Frame | Before and 28 Days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seropositivity was assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 19 | 8 |
| Serotype 1; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| Serotype 1; Post-Injection 1 (n=19, 8) |
42.1
42.1%
|
0
0%
|
| Serotype 1; Pre-Injection 2 (n=16, 8) |
31.3
31.3%
|
0
0%
|
| Serotype 1; Post-Injection 2 (n=16, 8) |
75.0
75%
|
0
0%
|
| Serotype 1; Pre-Injection 3 (n=16, 8) |
37.5
37.5%
|
12.5
25%
|
| Serotype 1; Post-Injection 3 (n=16, 8) |
87.5
87.5%
|
12.5
25%
|
| Serotype 2; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| Serotype 2; Post-Injection 1 (n=19, 8) |
26.3
26.3%
|
0
0%
|
| Serotype 2; Pre-Injection 2 (n=16, 8) |
25.0
25%
|
0
0%
|
| Serotype 2; Post-Injection 2 (n=16, 8) |
93.8
93.8%
|
0
0%
|
| Serotype 2; Pre-Injection 3 (n=16, 8) |
56.3
56.3%
|
12.5
25%
|
| Serotype 2; Post-Injection 3 (n=16, 8) |
93.8
93.8%
|
12.5
25%
|
| Serotype 3; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| Serotype 3; Post-Injection 1 (n=19, 8) |
84.2
84.2%
|
0
0%
|
| Serotype 3; Pre-Injection 2 (n=16, 8) |
68.8
68.8%
|
0
0%
|
| Serotype 3; Post-Injection 2 (n=16, 8) |
100.0
100%
|
0
0%
|
| Serotype 3; Pre-Injection 3 (n=15, 8) |
80.0
80%
|
12.5
25%
|
| Serotype 3; Post-Injection 3 (n=16, 8) |
100.0
100%
|
12.5
25%
|
| Serotype 4; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| Serotype 4; Post-Injection 1 (n=19, 8) |
68.4
68.4%
|
0
0%
|
| Serotype 4; Pre-Injection 2 (n=16, 8) |
81.3
81.3%
|
0
0%
|
| Serotype 4; Post-Injection 2 (n=16, 8) |
100.0
100%
|
0
0%
|
| Serotype 4; Pre-Injection 3 (n=15, 8) |
93.3
93.3%
|
12.5
25%
|
| Serotype 4; Post-Injection 3 (n=16, 8) |
100.0
100%
|
25
50%
|
| Title | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seropositivity was assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 99 | 49 |
| At least 1 serotype; Pre-Injection 1 (n=99, 49) |
68.7
68.7%
|
71.4
142.8%
|
| At least 1 serotype; Post-Injection 1 (n=99, 49) |
97.0
97%
|
71.4
142.8%
|
| At least 1 serotype; Pre-Injection 2 (n=94, 47) |
94.7
94.7%
|
74.5
149%
|
| At least 1 serotype; Post-Injection 2 (n=94, 47) |
100.0
100%
|
74.5
149%
|
| At least 1 serotype; Pre-Injection 3 (n=90, 46) |
98.9
98.9%
|
78.3
156.6%
|
| At least 1 serotype; Post-Injection 3 (n=89, 46) |
100.0
100%
|
78.3
156.6%
|
| At least 2 serotypes; Pre-Injection 1 (n=99, 49) |
62.6
62.6%
|
67.3
134.6%
|
| At least 2 serotypes; Post-Injection 1 (n=99, 49) |
91.9
91.9%
|
71.4
142.8%
|
| At least 2 serotypes; Pre-Injection 2 (n=94, 47) |
92.6
92.6%
|
74.5
149%
|
| At least 2 serotypes; Post-Injection 2 (n=94, 47) |
100.0
100%
|
72.3
144.6%
|
| At least 2 serotypes; Pre-Injection 3 (n=90, 46) |
91.1
91.1%
|
73.9
147.8%
|
| At least 2 serotypes; Post-Injection 3 (n=89, 46) |
100.0
100%
|
76.1
152.2%
|
| At least 3 serotypes; Pre-Injection 1 (n=99, 49) |
56.6
56.6%
|
61.2
122.4%
|
| At least 3 serotypes; Post-Injection 1 (n=99, 49) |
81.8
81.8%
|
65.3
130.6%
|
| At least 3 serotypes; Pre-Injection 2 (n=94, 47) |
81.9
81.9%
|
72.3
144.6%
|
| At least 3 serotypes; Post-Injection 2 (n=94, 47) |
98.9
98.9%
|
70.2
140.4%
|
| At least 3 serotypes; Pre-Injection 3 (n=90, 46) |
86.7
86.7%
|
71.7
143.4%
|
| At least 3 serotypes; Post-Injection 3 (n=89, 46) |
98.9
98.9%
|
71.7
143.4%
|
| All 4 serotypes; Pre-Injection 1 (n=99, 49) |
47.5
47.5%
|
46.9
93.8%
|
| All 4 serotypes; Post-Injection 1 (n=99, 49) |
72.7
72.7%
|
53.1
106.2%
|
| All 4 serotypes; Pre-Injection 2 (n=94, 47) |
74.5
74.5%
|
55.3
110.6%
|
| All 4 serotypes; Post-Injection 2 (n=94, 47) |
95.7
95.7%
|
59.6
119.2%
|
| All 4 serotypes; Pre-Injection 3 (n=90, 46) |
76.7
76.7%
|
63
126%
|
| All 4 serotypes; Post-Injection 3 (n=89, 46) |
96.6
96.6%
|
67.4
134.8%
|
| Title | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer. |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seropositivity was assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 80 | 41 |
| At least 1 serotype; Pre-Injection 1 (n=80, 41) |
85.0
85%
|
85.4
170.8%
|
| At least 1 serotype; Post-Injection 1 (n=80, 41) |
97.5
97.5%
|
85.4
170.8%
|
| At least 1 serotype; Pre-Injection 2 (n=78, 39) |
97.4
97.4%
|
89.7
179.4%
|
| At least 1 serotype; Post-Injection 2 (n=78, 39) |
100.0
100%
|
89.7
179.4%
|
| At least 1 serotype; Pre-Injection 3 (n=74, 38) |
100.0
100%
|
92.1
184.2%
|
| At least 1 serotype; Post-Injection 3 (n=73, 38) |
100.0
100%
|
89.5
179%
|
| At least 2 serotypes; Pre-Injection 1 (n=80, 41) |
77.5
77.5%
|
80.5
161%
|
| At least 2 serotypes; Post-Injection 1 (n=80, 41) |
95.0
95%
|
85.4
170.8%
|
| At least 2 serotypes; Pre-Injection 2 (n=78, 39) |
97.4
97.4%
|
89.7
179.4%
|
| At least 2 serotypes; Post-Injection 2 (n=78, 39) |
100.0
100%
|
87.2
174.4%
|
| At least 2 serotypes; Pre-Injection 3 (n=74, 38) |
95.9
95.9%
|
86.8
173.6%
|
| At least 2 serotypes; Post-Injection 3 (n=73, 38) |
100.0
100%
|
89.5
179%
|
| At least 3 serotypes; Pre-Injection 1 (n=80, 41) |
70.0
70%
|
73.2
146.4%
|
| At least 3 serotypes; Post-Injection 1 (n=80, 41) |
92.5
92.5%
|
78
156%
|
| At least 3 serotypes; Pre-Injection 2 (n=78, 39) |
91.0
91%
|
87.2
174.4%
|
| At least 3 serotypes; Post-Injection 2 (n=78, 39) |
100.0
100%
|
84.6
169.2%
|
| At least 3 serotypes; Pre-Injection 3 (n=74, 38) |
93.2
93.2%
|
84.2
168.4%
|
| At least 3 serotypes; Post-Injection 3 (n=73, 38) |
100.0
100%
|
84.2
168.4%
|
| All 4 serotypes; Pre-Injection 1 (n=80, 41) |
58.8
58.8%
|
56.1
112.2%
|
| All 4 serotypes; Post-Injection 1 (n=80, 41) |
87.5
87.5%
|
63.4
126.8%
|
| All 4 serotypes; Pre-Injection 2 (n=78, 39) |
85.9
85.9%
|
66.7
133.4%
|
| All 4 serotypes; Post-Injection 2 (n=78, 39) |
100.0
100%
|
71.8
143.6%
|
| All 4 serotypes; Pre-Injection 3 (n=74, 38) |
85.1
85.1%
|
73.7
147.4%
|
| All 4 serotypes; Post-Injection 3 (n=73, 38) |
98.6
98.6%
|
78.9
157.8%
|
| Title | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer. |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seropositivity was assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 19 | 8 |
| At least 1 serotype; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| At least 1 serotype; Post-Injection 1 (n=19, 8) |
94.7
94.7%
|
0
0%
|
| At least 1 serotype; Pre-Injection 2 (n=16, 8) |
81.3
81.3%
|
0
0%
|
| At least 1 serotype; Post-Injection 2 (n=16, 8) |
100.0
100%
|
0
0%
|
| At least 1 serotype; Pre-Injection 3 (n=16, 8) |
93.8
93.8%
|
12.5
25%
|
| At least 1 serotype; Post-Injection 3 (n=16, 8) |
100.0
100%
|
25
50%
|
| At least 2 serotypes; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| At least 2 serotypes; Post-Injection 1 (n=19, 8) |
78.9
78.9%
|
0
0%
|
| At least 2 serotypes; Pre-Injection 2 (n=16, 8) |
68.8
68.8%
|
0
0%
|
| At least 2 serotypes; Post-Injection 2 (n=16, 8) |
100.0
100%
|
0
0%
|
| At least 2 serotypes; Pre-Injection 3 (n=16, 8) |
68.8
68.8%
|
12.5
25%
|
| At least 2 serotypes; Post-Injection 3 (n=16, 8) |
100.0
100%
|
12.5
25%
|
| At least 3 serotypes; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| At least 3 serotypes; Post-Injection 1 (n=19, 8) |
36.8
36.8%
|
0
0%
|
| At least 3 serotypes; Pre-Injection 2 (n=16, 8) |
37.5
37.5%
|
0
0%
|
| At least 3 serotypes; Post-Injection 2 (n=16, 8) |
93.8
93.8%
|
0
0%
|
| At least 3 serotypes; Pre-Injection 3 (n=16, 8) |
56.3
56.3%
|
12.5
25%
|
| At least 3 serotypes; Post-Injection 3 (n=16, 8) |
93.8
93.8%
|
12.5
25%
|
| All 4 serotypes; Pre-Injection 1 (n=19, 8) |
0.0
0%
|
0
0%
|
| All 4 serotypes; Post-Injection 1 (n=19, 8) |
10.5
10.5%
|
0
0%
|
| All 4 serotypes; Pre-Injection 2 (n=16, 8) |
18.8
18.8%
|
0
0%
|
| All 4 serotypes; Post-Injection 2 (n=16, 8) |
75.0
75%
|
0
0%
|
| All 4 serotypes; Pre-Injection 3 (n=16, 8) |
37.5
37.5%
|
12.5
25%
|
| All 4 serotypes; Post-Injection 3 (n=16, 8) |
87.5
87.5%
|
12.5
25%
|
| Title | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titer ratios were assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 99 | 49 |
| Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) |
4.67
|
0.834
|
| Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) |
7.26
|
2.11
|
| Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) |
1.66
|
1.25
|
| Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) |
4.92
|
1.36
|
| Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) |
1.07
|
0.793
|
| Serotype 1; Post -nj. 3 / Pre-Inj. 3 (n=89, 46) |
1.48
|
0.706
|
| Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) |
4.15
|
0.733
|
| Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) |
6.80
|
1.75
|
| Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) |
1.97
|
0.981
|
| Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) |
6.21
|
1.68
|
| Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) |
1.78
|
0.944
|
| Serotype 2; Post-Inj. 3 / Pre-Inj. 3 (n=89, 46) |
1.40
|
0.851
|
| Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) |
6.50
|
0.916
|
| Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) |
8.57
|
1.85
|
| Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) |
2.03
|
1.02
|
| Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) |
6.26
|
1.24
|
| Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) |
1.46
|
0.673
|
| Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46) |
1.53
|
0.8
|
| Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48) |
17.7
|
0.806
|
| Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) |
15.4
|
1.27
|
| Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) |
1.84
|
0.835
|
| Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) |
20.2
|
1.4
|
| Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) |
2.26
|
0.912
|
| Serotype 4; Post -nj. 3 / Pre-Inj. 3 (n=87, 46) |
1.68
|
0.723
|
| Title | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titers were assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 99 | 49 |
| Serotype 1; Pre-Injection 1 (n=99, 49) |
41.4
|
47.2
|
| Serotype 1; Post-Injection 1 (n=99, 49) |
256
|
50.7
|
| Serotype 1; Pre-Injection 2 (n=94, 47) |
230
|
86
|
| Serotype 1; Post-Injection 2 (n=94, 47) |
436
|
130
|
| Serotype 1; Pre-Injection 3 (n=90, 46) |
162
|
90.8
|
| Serotype 1; Post-Injection 3 (n=89, 46) |
267
|
79.2
|
| Serotype 2; Pre-Injection 1 (n=99, 49) |
67.0
|
68.3
|
| Serotype 2; Post-Injection 1 (n=99, 49) |
352
|
62.8
|
| Serotype 2; Pre-Injection 2 (n=94, 47) |
287
|
117
|
| Serotype 2; Post-Injection 2 (n=94, 47) |
647
|
137
|
| Serotype 2; Pre-Injection 3 (n=90, 46) |
360
|
131
|
| Serotype 2; Post-Injection 3 (n=89, 46) |
544
|
132
|
| Serotype 3; Pre-Injection 1 (n=99, 49) |
81.9
|
94.7
|
| Serotype 3; Post-Injection 1 (n=99, 49) |
690
|
110
|
| Serotype 3; Pre-Injection 2 (n=94, 47) |
471
|
184
|
| Serotype 3; Post-Injection 2 (n=94, 47) |
1031
|
227
|
| Serotype 3; Pre-Injection 3 (n=89, 46) |
481
|
144
|
| Serotype 3; Post-Injection 3 (n=89, 46) |
741
|
140
|
| Serotype 4; Pre-Injection 1 (n=99, 49) |
15.0
|
17.5
|
| Serotype 4; Post-Injection 1 (n=99, 48) |
383
|
19.2
|
| Serotype 4; Pre-Injection 2 (n=94, 47) |
178
|
27.8
|
| Serotype 4; Post-Injection 2 (n=94, 47) |
346
|
31.2
|
| Serotype 4; Pre-Injection 3 (n=88, 46) |
258
|
37.4
|
| Serotype 4; Post-Injection 3 (n=89, 46) |
432
|
33.4
|
| Title | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer. |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titers were assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 80 | 41 |
| Serotype 1; Pre-Injection 1 (n=80, 41) |
68.5
|
73.1
|
| Serotype 1; Post-Injection 1 (n=80, 41) |
549
|
79.8
|
| Serotype 1; Pre-Injection 2 (n=78, 39) |
430
|
154
|
| Serotype 1; Post-Injection 2 (n=78, 39) |
661
|
253
|
| Serotype 1; Pre-Injection 3 (n=74, 38) |
268
|
143
|
| Serotype 1; Post-Injection 3 (n=73, 38) |
381
|
126
|
| Serotype 2; Pre-Injection 1 (n=80, 41) |
124
|
114
|
| Serotype 2; Post-Injection 1 (n=80, 41) |
816
|
103
|
| Serotype 2; Pre-Injection 2 (n=78, 39) |
591
|
224
|
| Serotype 2; Post-Injection 2 (n=78, 39) |
978
|
271
|
| Serotype 2; Pre-Injection 3 (n=74, 38) |
648
|
240
|
| Serotype 2; Post-Injection 3 (n=73, 38) |
835
|
242
|
| Serotype 3; Pre-Injection 1 (n=80, 41) |
159
|
168
|
| Serotype 3; Post-Injection 1 (n=80, 41) |
1263
|
202
|
| Serotype 3; Pre-Injection 2 (n=78, 39) |
879
|
387
|
| Serotype 3; Post-Injection 2 (n=78, 39) |
1426
|
497
|
| Serotype 3; Pre-Injection 3 (n=74, 38) |
776
|
272
|
| Serotype 3; Post-Injection 3 (n=73, 38) |
1031
|
266
|
| Serotype 4; Pre-Injection 1 (n=80, 41) |
19.5
|
22.4
|
| Serotype 4; Post-Injection 1 (n=80, 40) |
467
|
25.2
|
| Serotype 4; Pre-Injection 2 (n=78, 39) |
220
|
39.5
|
| Serotype 4; Post-Injection 2 (n=78, 39) |
377
|
45.3
|
| Serotype 4; Pre-Injection 3 (n=73, 38) |
313
|
53.9
|
| Serotype 4; Post-Injection 3 (n=73, 38) |
485
|
46.5
|
| Title | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer. |
| Time Frame | Before and 28 days after each injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titer ratios were assessed in the Full Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 19 | 8 |
| Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) |
1.03
|
0.5
|
| Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) |
5.73
|
0.5
|
| Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) |
3.25
|
0.5
|
| Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) |
5.34
|
0.861
|
| Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) |
3.03
|
0.861
|
| Serotype 1; Post-Inj. 3 / Pre-Inj. 3 (n=16, 8) |
2.19
|
0.446
|
| Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) |
1.02
|
0.5
|
| Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) |
8.62
|
0.5
|
| Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) |
6.02
|
0.5
|
| Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) |
7.67
|
0.737
|
| Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) |
5.36
|
0.737
|
| Serotype 2; Post -nj. 3 / Pre-Inj. 3 (n=16, 8) |
2.37
|
0.538
|
| Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) |
5.41
|
0.5
|
| Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) |
21.2
|
0.5
|
| Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) |
7.58
|
0.5
|
| Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) |
16.3
|
0.678
|
| Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) |
5.83
|
0.678
|
| Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8) |
3.35
|
0.524
|
| Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) |
16.5
|
0.5
|
| Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) |
22.7
|
0.5
|
| Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) |
3.15
|
0.5
|
| Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) |
25.5
|
0.701
|
| Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) |
3.53
|
0.701
|
| Serotype 4; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8) |
2.55
|
0.578
|
| Title | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo |
|---|---|
| Description | Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity. |
| Time Frame | Day 0 up to Day 14 post each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. |
| Measure Participants | 100 | 50 |
| Injection-site Pain; Post-Any Injection (N=100,49) |
40
40%
|
40.8
81.6%
|
| Grade 3 Inj.-site Pain; Post-Any Inj. (N=100,49) |
0
0%
|
4.1
8.2%
|
| Inj.-site Erythema; Post-Any Inj. (N=100,49) |
4.0
4%
|
2
4%
|
| Gr 3 Inj.-site Erythema; Post-Any Inj. (N=100,49) |
0
0%
|
0
0%
|
| Inj.-site Swelling; Post-Any Inj. (N=100,49) |
5.0
5%
|
4.1
8.2%
|
| Gr 3 Inj.-site Swelling; Post-Any Inj. (N=100,49) |
0
0%
|
0
0%
|
| Injection-site Pain; Post-Injection 1 (N=99,49) |
26.3
26.3%
|
30.6
61.2%
|
| Gr 3 Inj.-site Pain; Post-Inj. 1 (N=99,49) |
0
0%
|
2
4%
|
| Inj.-site Erythema; Post-Inj. 1 (N=99,49) |
1.0
1%
|
2
4%
|
| Gr 3 Inj.-site Erythema; Post-Inj. 1 (N=99,49) |
0
0%
|
0
0%
|
| Inj.-site Swelling; Post-Inj. 1 (N=99,49) |
2.0
2%
|
4.1
8.2%
|
| Gr 3 Inj.-site Swelling; Post-Inj. 1 (N=99,49) |
0
0%
|
0
0%
|
| Injection-site Pain; Post-Injection 2 (N=93,47) |
21.5
21.5%
|
14.9
29.8%
|
| Gr 3 Inj.-site Pain; Post-Inj. 2 (N=93,47) |
0
0%
|
2.1
4.2%
|
| Inj.-site Erythema; Post-Inj. 2 (N=93,47) |
3.2
3.2%
|
0
0%
|
| Gr 3 Inj.-site Erythema; Post-Inj. 2 (N=93,47) |
0
0%
|
0
0%
|
| Inj.-site Swelling; Post-Inj. 2 (N=93,47) |
2.2
2.2%
|
0
0%
|
| Gr 3 Inj.-site Swelling; Post-Inj. 2 (N=93,47) |
0
0%
|
0
0%
|
| Injection-site Pain; Post-Injection 3 (N=89,45) |
16.9
16.9%
|
15.6
31.2%
|
| Gr 3 Inj.-site Pain; Post-Inj. 3 (N=89,45) |
0
0%
|
2.2
4.4%
|
| Inj.-site Erythema; Post-Inj. 3 (N=89,45) |
0
0%
|
0
0%
|
| Gr 3 Inj.-site Erythema; Post-Inj. 3 (N=89,45) |
0
0%
|
0
0%
|
| Inj.-site Swelling; Post-Inj. 3 (N=89,45) |
1.1
1.1%
|
0
0%
|
| Gr 3 Inj.-site Swelling; Post-Inj. 3 (N=89,45) |
0
0%
|
0
0%
|
| Fever; Post-Any Injection (N=100, 49) |
30.0
30%
|
18.4
36.8%
|
| Grade 3 Fever; Post-Any Injection (N=100, 49) |
8.0
8%
|
6.1
12.2%
|
| Headache; Post-Any Injection (N=100, 49) |
61.0
61%
|
51
102%
|
| Grade 3 Headache; Post-Any Injection (N=100, 49) |
15.0
15%
|
20.4
40.8%
|
| Malaise; Post-Any Injection (N=100, 49) |
40.0
40%
|
32.7
65.4%
|
| Grade 3 Malaise; Post-Any Injection (N=100, 49) |
11.0
11%
|
6.1
12.2%
|
| Myalgia; Post-Any Injection (N=100, 49) |
42.0
42%
|
42.9
85.8%
|
| Grade 3 Myalgia; Post-Any Injection (N=100, 49) |
6.0
6%
|
8.2
16.4%
|
| Asthenia; Post-Any Injection (N=100, 49) |
35.0
35%
|
20.4
40.8%
|
| Grade 3 Asthenia; Post-Any Injection (N=100, 49) |
8.0
8%
|
4.1
8.2%
|
| Fever; Post-Injection 1 (N=98, 48) |
15.3
15.3%
|
10.4
20.8%
|
| Grade 3 Fever; Post-Injection 1 (N=98, 48) |
3.1
3.1%
|
2.1
4.2%
|
| Headache; Post-Injection 1 (N=99, 49) |
48.5
48.5%
|
40.8
81.6%
|
| Grade 3 Headache; Post-Injection 1 (N=99, 49) |
8.1
8.1%
|
10.2
20.4%
|
| Malaise; Post-Injection 1 (N=99, 49) |
31.3
31.3%
|
18.4
36.8%
|
| Grade 3 Malaise; Post-Injection 1 (N=99, 49) |
3.0
3%
|
2
4%
|
| Myalgia; Post-Injection 1 (N=99, 49) |
32.3
32.3%
|
30.6
61.2%
|
| Grade 3 Myalgia; Post-Injection 1 (N=99, 49) |
2.0
2%
|
6.1
12.2%
|
| Asthenia; Post-Injection 1 (N=99, 49) |
22.2
22.2%
|
10.2
20.4%
|
| Grade 3 Asthenia; Post-Injection 1 (N=99, 49) |
4.0
4%
|
4.1
8.2%
|
| Fever; Post-Injection 2 (N=92, 47) |
8.7
8.7%
|
4.3
8.6%
|
| Grade 3 Fever; Post-Injection 2 (N=92, 47) |
2.2
2.2%
|
0
0%
|
| Headache; Post-Injection 2 (N=94, 47) |
28.7
28.7%
|
34
68%
|
| Grade 3 Headache; Post-Injection 2 (N=94, 47) |
5.3
5.3%
|
6.4
12.8%
|
| Malaise; Post-Injection 2 (N=94, 47) |
18.1
18.1%
|
17
34%
|
| Grade 3 Malaise; Post-Injection 2 (N=94, 47) |
6.4
6.4%
|
4.3
8.6%
|
| Myalgia; Post-Injection 2 (N=94, 47) |
20.2
20.2%
|
21.3
42.6%
|
| Grade 3 Myalgia; Post-Injection 2 (N=94, 47) |
3.2
3.2%
|
4.3
8.6%
|
| Asthenia; Post-Injection 2 (N=94, 47) |
12.8
12.8%
|
14.9
29.8%
|
| Grade 3 Asthenia; Post-Injection 2 (N=94, 47) |
3.2
3.2%
|
0
0%
|
| Fever; Post-Injection 3 (N=82, 43) |
11.0
11%
|
7
14%
|
| Grade 3 Fever; Post-Injection 3 (N=82, 43) |
3.7
3.7%
|
7
14%
|
| Headache; Post-Injection 3 (N=89, 45) |
27.0
27%
|
20
40%
|
| Grade 3 Headache; Post-Injection 3 (N=89, 45) |
5.6
5.6%
|
8.9
17.8%
|
| Malaise; Post-Injection 3 (N=89, 45) |
15.7
15.7%
|
11.1
22.2%
|
| Grade 3 Malaise; Post-Injection 3 (N=89, 45) |
2.2
2.2%
|
0
0%
|
| Myalgia; Post-Injection 3 (N=89, 45) |
20.2
20.2%
|
11.1
22.2%
|
| Grade 3 Myalgia; Post-Injection 3 (N=89, 45) |
2.2
2.2%
|
0
0%
|
| Asthenia; Post-Injection 3 (N=89, 45) |
14.6
14.6%
|
4.4
8.8%
|
| Grade 3 Asthenia; Post-Injection 3 (N=89, 45) |
2.2
2.2%
|
0
0%
|
Adverse Events
| Time Frame | Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group | ||
| Arm/Group Description | Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. | ||
All Cause Mortality |
||||
| CYD Dengue Vaccine Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| CYD Dengue Vaccine Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/100 (5%) | 3/50 (6%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/100 (0%) | 0 | 1/50 (2%) | 1 |
| Food poisoning | 1/100 (1%) | 1 | 0/50 (0%) | 0 |
| Infections and infestations | ||||
| Abdominal wall abscess | 1/100 (1%) | 1 | 0/50 (0%) | 0 |
| Appendicitis | 1/100 (1%) | 1 | 1/50 (2%) | 1 |
| Cellulitis | 2/100 (2%) | 2 | 0/50 (0%) | 0 |
| Gastroenteritis | 0/100 (0%) | 0 | 1/50 (2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Multiple injuries | 0/100 (0%) | 0 | 1/50 (2%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Intra uterine death | 1/100 (1%) | 1 | 0/50 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| CYD Dengue Vaccine Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/100 (61%) | 25/50 (50%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 9/100 (9%) | 9 | 1/50 (2%) | 2 |
| Eye disorders | ||||
| Conjunctivitis | 11/100 (11%) | 11 | 7/50 (14%) | 7 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 12/100 (12%) | 16 | 4/50 (8%) | 6 |
| Nausea | 8/100 (8%) | 11 | 0/50 (0%) | 0 |
| Vomiting | 7/100 (7%) | 7 | 2/50 (4%) | 2 |
| General disorders | ||||
| Injection site Pain; Post Any Injection | 40/100 (40%) | 40 | 20/49 (40.8%) | 20 |
| Injection site Swelling; Post Any Injection | 5/100 (5%) | 5 | 2/49 (4.1%) | 2 |
| Fever; Post Any Injection | 30/100 (30%) | 30 | 9/49 (18.4%) | 9 |
| Malaise; Post-Any Injection | 40/100 (40%) | 40 | 16/49 (32.7%) | 16 |
| Asthenia; Post-Any Injection | 35/100 (35%) | 35 | 10/49 (20.4%) | 10 |
| Infections and infestations | ||||
| Nasopharyngitis | 12/100 (12%) | 12 | 6/50 (12%) | 6 |
| Rhinitis | 6/100 (6%) | 7 | 2/50 (4%) | 2 |
| Tonsillitis | 5/100 (5%) | 5 | 0/50 (0%) | 0 |
| Upper respiratory tract infection | 18/100 (18%) | 19 | 3/50 (6%) | 3 |
| Injury, poisoning and procedural complications | ||||
| Limb injury | 6/100 (6%) | 6 | 4/50 (8%) | 4 |
| Wound | 0/100 (0%) | 0 | 3/50 (6%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia; Post-Any Injection | 42/100 (42%) | 42 | 21/49 (42.9%) | 21 |
| Nervous system disorders | ||||
| Headache: Post Any Injection | 61/100 (61%) | 61 | 25/49 (51%) | 25 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 6/100 (6%) | 7 | 4/50 (8%) | 4 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur Inc. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01187433
Other Study ID Numbers:
- CYD30
- UTN: U1111-1111-6073
First Posted:
Aug 24, 2010
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022