Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00788151
Collaborator
(none)
300
1
2
22.6
13.3
Study Details
Study Description
Brief Summary
The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.
Primary Objectives:
-
To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
-
To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
-
To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.
Study Design
Study Type:
Interventional
Actual Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru
Actual Study Start Date
:
Sep 26, 2008
Actual Primary Completion Date
:
Feb 16, 2010
Actual Study Completion Date
:
Aug 16, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CYD Dengue vaccine group Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). |
Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4
0.5 mL, Subcutaneous (SC)
Other Names:
|
| Placebo Comparator: Control group Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
Biological: Pneumococcal polysaccharide vaccine
0.5 mL, SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo [Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3]
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
- Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo [Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3]
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
- Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo [Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3]
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Secondary Outcome Measures
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution.
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution.
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution.
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
- Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo [Pre-Injection 1 and 28 days Post-Injection 2 and 3]
GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
- Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo [Pre-Injection 1 and 28 days Post-Injection 1]
Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
- GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo [Pre-Injection 1 and 28 days Post-Injection 1]
GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
- GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo [Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3]
GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Aged 2 to 11 years on the day of inclusion.
-
Participant in good health, based on medical history, physical examination and laboratory parameters.
-
Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
-
Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
-
For a female participant of child-bearing potential (girls post-menarche), 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.
-
Documented receipt of yellow fever vaccine since at least one month before the first vaccination.
Exclusion Criteria :
-
Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
-
For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
-
For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.
-
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
-
Planned participation in another clinical trial during the trial.
-
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 vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
-
Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
-
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
-
Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
-
Receipt of any blood or blood-derived products in the past 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.
-
Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
-
Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
-
Known previous vaccination with pneumococcal polysaccharide vaccine.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chulucanas Morropon | Piura | Peru |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Monitor, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00788151
Other Study ID Numbers:
- CYD24
- 2014-001711-40
First Posted:
Nov 10, 2008
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru. |
|---|---|
| Pre-assignment Detail | A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. Two participants were not vaccinated and were excluded from the Full analysis set and Safety analysis set. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Period Title: Overall Study | ||
| STARTED | 200 | 100 |
| Received Vaccination 1 | 199 | 99 |
| Received Vaccination 2 | 188 | 92 |
| Received Vaccination 3 | 186 | 90 |
| COMPLETED | 186 | 90 |
| NOT COMPLETED | 14 | 10 |
Baseline Characteristics
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). | Total of all reporting groups |
| Overall Participants | 199 | 99 | 298 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
6.4
(2.8)
|
6.4
(2.9)
|
6.4
(2.9)
|
| Age, Customized (Count of Participants) | |||
| 2 to 5 years |
100
50.3%
|
50
50.5%
|
150
50.3%
|
| 6 to 11 years |
99
49.7%
|
49
49.5%
|
148
49.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
98
49.2%
|
53
53.5%
|
151
50.7%
|
| Male |
101
50.8%
|
46
46.5%
|
147
49.3%
|
Outcome Measures
| Title | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities. |
| Time Frame | Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Inj. site Pain; Post-Inj. 1 (2-11 years) |
20.6
10.4%
|
17.2
17.4%
|
| Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Erythema; Post-Inj. 1 (2-11 years) |
7.5
3.8%
|
4.0
4%
|
| Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Swelling; Post-Inj. 1 (2-11 years) |
5.5
2.8%
|
5.1
5.2%
|
| Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Pain; Post-Inj. 2 (2-11 years) |
19.7
9.9%
|
17.4
17.6%
|
| Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years) |
0.0
0%
|
1.1
1.1%
|
| Inj. site Erythema; Post-Inj. 2 (2-11 years) |
4.3
2.2%
|
1.1
1.1%
|
| Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Swelling; Post-Inj. 2 (2-11 years) |
2.1
1.1%
|
0.0
0%
|
| Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Pain; Post-Inj. 3 (2-11 years) |
17.7
8.9%
|
32.2
32.5%
|
| Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years) |
0.5
0.3%
|
2.2
2.2%
|
| Inj. site Erythema; Post-Inj. 3 (2-11 years) |
4.3
2.2%
|
11.1
11.2%
|
| Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years) |
0.0
0%
|
3.3
3.3%
|
| Inj. site Swelling; Post-Inj. 3 (2-11 years) |
3.2
1.6%
|
8.9
9%
|
| Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years) |
0.0
0%
|
3.3
3.3%
|
| Fever; Post-Inj. 1 (2-11 years) |
31.3
15.7%
|
10.1
10.2%
|
| Grade 3 Fever; Post-Inj. 1 (2-11 years) |
3.5
1.8%
|
0.0
0%
|
| Headache; Post-Inj. 1 (2-11 years) |
35.7
17.9%
|
16.2
16.4%
|
| Grade 3 Headache; Post-Inj. 1 (2-11 years) |
0.5
0.3%
|
0.0
0%
|
| Malaise; Post-Inj. 1 (2-11 years) |
33.7
16.9%
|
23.2
23.4%
|
| Grade 3 Malaise; Post-Inj. 1 (2-11 years) |
0.5
0.3%
|
0.0
0%
|
| Myalgia; Post-Inj. 1 (2-11 years) |
19.1
9.6%
|
13.1
13.2%
|
| Grade 3 Myalgia; Post-Inj. 1 (2-11 years) |
0.0
0%
|
0.0
0%
|
| Asthenia; Post-Inj. 1 (2-11 years) |
13.6
6.8%
|
13.1
13.2%
|
| Grade 3 Asthenia; Post-Inj. 1 (2-11 years) |
0.5
0.3%
|
0.0
0%
|
| Fever; Post-Inj. 2 (2-11 years) |
19.7
9.9%
|
16.3
16.5%
|
| Grade 3 Fever; Post-Inj. 2 (2-11 years) |
0.5
0.3%
|
0.0
0%
|
| Headache; Post-Inj. 2 (2-11 years) |
22.3
11.2%
|
19.6
19.8%
|
| Grade 3 Headache; Post-Inj. 2 (2-11 years) |
0.5
0.3%
|
1.1
1.1%
|
| Malaise; Post-Inj. 2 (2-11 years) |
18.1
9.1%
|
16.3
16.5%
|
| Grade 3 Malaise; Post-Inj. 2 (All ages) |
0.5
0.3%
|
2.2
2.2%
|
| Myalgia; Post-Inj. 2 (2-11 years) |
14.9
7.5%
|
10.9
11%
|
| Grade 3 Myalgia; Post-Inj. 2 (2-11 years) |
1.1
0.6%
|
0.0
0%
|
| Asthenia; Post-Inj. 2 (2-11 years) |
11.2
5.6%
|
7.6
7.7%
|
| Grade 3 Asthenia; Post-Inj. 2 (2-11 years) |
0.5
0.3%
|
1.1
1.1%
|
| Fever; Post-Inj. 3 (2-11 years) |
18.4
9.2%
|
22.5
22.7%
|
| Grade 3 Fever; Post-Inj. 3 (2-11 years) |
0.0
0%
|
3.4
3.4%
|
| Headache; Post-Inj. 3 (2-11 years) |
18.8
9.4%
|
27.8
28.1%
|
| Grade 3 Headache; Post-Inj. 3 (2-11 years) |
0.0
0%
|
3.3
3.3%
|
| Malaise; Post-Inj. 3 (2-11 years) |
16.7
8.4%
|
23.3
23.5%
|
| Grade 3 Malaise; Post-Inj. 3 (2-11 years) |
0.0
0%
|
2.2
2.2%
|
| Myalgia; Post-Inj. 3 (2-11 years) |
13.4
6.7%
|
26.7
27%
|
| Grade 3 Myalgia; Post-Inj. 3 (2-11 years) |
0.0
0%
|
2.2
2.2%
|
| Asthenia; Post-Inj. 3 (2-11 years) |
10.2
5.1%
|
16.7
16.9%
|
| Grade 3 Asthenia; Post-Inj. 3 (2-11 years) |
0.0
0%
|
1.1
1.1%
|
| Title | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities. |
| Time Frame | Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 100 | 50 |
| Inj. site Pain: Post-Inj.1 (2-5 years) |
19.0
9.5%
|
16.0
16.2%
|
| Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Erythema; Post-Inj. 1 (2-5 years) |
11.0
5.5%
|
6.0
6.1%
|
| Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Swelling; Post-Inj. 1 (2-5 years) |
6.0
3%
|
8.0
8.1%
|
| Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Pain; Post-Inj. 2 (2-5 years) |
17.4
8.7%
|
15.6
15.8%
|
| Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years) |
0.0
0%
|
2.2
2.2%
|
| Inj. site Erythema; Post-Inj. 2 (2-5 years) |
4.3
2.2%
|
0.0
0%
|
| Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Swelling; Post-Inj. 2 (2-5 years) |
2.2
1.1%
|
0.0
0%
|
| Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Pain; Post-Inj. 3 (2-5 years) |
14.4
7.2%
|
23.3
23.5%
|
| Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years) |
0.0
0%
|
4.7
4.7%
|
| Inj. site Erythema; Post-Inj. 3 (2-5 years) |
3.3
1.7%
|
9.3
9.4%
|
| Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years |
0.0
0%
|
2.3
2.3%
|
| Inj. site Swelling; Post-Inj. 3 (2-5 years) |
3.3
1.7%
|
7.0
7.1%
|
| Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years) |
0.0
0%
|
2.3
2.3%
|
| Fever; Post-Inj. 1 (2-5 years) |
36.4
18.3%
|
16.0
16.2%
|
| Grade 3 Fever; Post-Inj. 1 (2-5 years) |
4.0
2%
|
0.0
0%
|
| Headache; Post-Inj. 1 (2-5 years) |
23.0
11.6%
|
8.0
8.1%
|
| Grade 3 Headache; Post-Inj. 1 (2-5 years) |
1.0
0.5%
|
0.0
0%
|
| Malaise; Post-Inj. 1 (2-5 years) |
33.0
16.6%
|
26.0
26.3%
|
| Grade 3 Malaise; Post-Inj. 1 (2-5 years) |
1.0
0.5%
|
0.0
0%
|
| Myalgia; Post-Inj. 1 (2-5 years) |
12.0
6%
|
10.0
10.1%
|
| Grade 3 Myalgia; Post-Inj. 1 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Asthenia; Post-Inj. 1 (2-5 years) |
13.0
6.5%
|
12.0
12.1%
|
| Grade 3 Asthenia; Post-Inj. 1 (2-5 years) |
1.0
0.5%
|
0.0
0%
|
| Fever; Post-Inj. 2 (2-5 years) |
23.9
12%
|
17.8
18%
|
| Grade 3 Fever; Post-Inj. 2 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Headache; Post-Inj. 2 (2-5 years) |
14.1
7.1%
|
6.7
6.8%
|
| Grade 3 Headache; Post-Inj. 2 (2-5 years) |
0.0
0%
|
0.0
0%
|
| Malaise; Post-Inj. 2 (2-5 years) |
15.2
7.6%
|
13.3
13.4%
|
| Grade 3 Malaise; Post-Inj. 2 (2-5 years) |
1.1
0.6%
|
2.2
2.2%
|
| Myalgia; Post-Inj. 2 (2-5 years) |
9.8
4.9%
|
6.7
6.8%
|
| Grade 3 Myalgia; Post-Inj. 2 (2-5 years) |
1.1
0.6%
|
0.0
0%
|
| Asthenia; Post-Inj. 2 (2-5 years) |
9.8
4.9%
|
8.9
9%
|
| Grade 3 Asthenia; Post-Inj. 2 (2-5 years) |
1.1
0.6%
|
2.2
2.2%
|
| Fever; Post-Inj. 3 (2-5 years) |
16.9
8.5%
|
26.2
26.5%
|
| Grade 3 Fever; Post-Inj. 3 (2-5 years) |
0.0
0%
|
7.1
7.2%
|
| Headache; Post-Inj. 3 (2-5 years) |
6.7
3.4%
|
18.6
18.8%
|
| Grade 3 Headache; Post-Inj. 3 (2-5 years) |
0.0
0%
|
2.3
2.3%
|
| Malaise; Post-Inj. 3 (2-5 years) |
6.7
3.4%
|
23.3
23.5%
|
| Grade 3 Malaise; Post-Inj. 3 (2-5 years) |
0.0
0%
|
2.3
2.3%
|
| Myalgia; Post-Inj. 3 (2-5 years) |
6.7
3.4%
|
20.9
21.1%
|
| Grade 3 Myalgia; Post-Inj. 3 (2-5 years) |
0.0
0%
|
2.3
2.3%
|
| Asthenia; Post-Inj. 3 (2-5 years) |
4.4
2.2%
|
23.3
23.5%
|
| Grade 3 Asthenia; Post-Inj. 3 (2-5 years) |
0.0
0%
|
2.3
2.3%
|
| Title | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities. |
| Time Frame | Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 99 | 49 |
| Inj. site Pain; Post-Inj.1 (6-11 years) |
22.2
11.2%
|
18.4
18.6%
|
| Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Erythema; Post-Inj. 1 (6-11 years) |
4.0
2%
|
2.0
2%
|
| Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Swelling; Post-Inj. 1 (6-11 years) |
5.1
2.6%
|
2.0
2%
|
| Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Pain; Post-Inj. 2 (6-11 years) |
21.9
11%
|
19.1
19.3%
|
| Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Erythema; Post-Inj. 2 (6-11 years) |
4.2
2.1%
|
2.1
2.1%
|
| Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Swelling; Post-Inj. 2 (6-11 years) |
2.1
1.1%
|
0.0
0%
|
| Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years) |
0.0
0%
|
0.0
0%
|
| Inj. site Pain; Post-Inj. 3 (6-11 years) |
20.8
10.5%
|
40.4
40.8%
|
| Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years) |
1.0
0.5%
|
0.0
0%
|
| Inj. site Erythema; Post-Inj. 3 (6-11 years) |
5.2
2.6%
|
12.8
12.9%
|
| Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years) |
0.0
0%
|
4.3
4.3%
|
| Inj. site Swelling; Post-Inj. 3 (6-11 years) |
3.1
1.6%
|
10.6
10.7%
|
| Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years) |
0.0
0%
|
4.3
4.3%
|
| Fever; Post-Inj. 1 (6-11 years) |
26.3
13.2%
|
4.1
4.1%
|
| Grade 3 Fever; Post-Inj. 1 (6-11 years) |
3.0
1.5%
|
0.0
0%
|
| Headache; Post-Inj. 1 (6-11 years) |
48.5
24.4%
|
24.5
24.7%
|
| Grade 3 Headache; Post-Inj. 1 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Malaise; Post-Inj. 1 (6-11 years) |
34.3
17.2%
|
20.4
20.6%
|
| Grade 3 Malaise; Post-Inj. 1 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Myalgia; Post-Inj. 1 (6-11 years) |
26.3
13.2%
|
16.3
16.5%
|
| Grade 3 Myalgia; Post-Inj. 1 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Asthenia; Post-Inj. 1 (6-11 years) |
14.1
7.1%
|
14.3
14.4%
|
| Grade 3 Asthenia; Post-Inj. 1 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Fever; Post-Inj. 2 (6-11 years) |
15.6
7.8%
|
14.9
15.1%
|
| Grade 3 Fever; Post-Inj. 2 (6-11 years) |
1.0
0.5%
|
0.0
0%
|
| Headache; Post-Inj. 2 (6-11 years) |
30.2
15.2%
|
31.9
32.2%
|
| Grade 3 Headache; Post-Inj. 2 (6-11 years) |
1.0
0.5%
|
2.1
2.1%
|
| Malaise; Post-Inj. 2 (6-11 years) |
20.8
10.5%
|
19.1
19.3%
|
| Grade 3 Malaise; Post-Inj. 2 (6-11 years) |
0.0
0%
|
2.1
2.1%
|
| Myalgia; Post-Inj. 2 (6-11 years) |
19.8
9.9%
|
14.9
15.1%
|
| Grade 3 Myalgia; Post-Inj. 2 (6-11 years) |
1.0
0.5%
|
0.0
0%
|
| Asthenia; Post-Inj. 2 (6-11 years) |
12.5
6.3%
|
6.4
6.5%
|
| Grade 3 Asthenia; Post-Inj. 2 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Fever; Post-Inj. 3 (6-11 years) |
19.8
9.9%
|
19.1
19.3%
|
| Grade 3 Fever; Post-Inj. 3 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Headache; Post-Inj. 3 (6-11 years) |
30.2
15.2%
|
36.2
36.6%
|
| Grade 3 Headache; Post-Inj. 3 (6-11 years) |
0.0
0%
|
4.3
4.3%
|
| Malaise; Post-Inj. 3 (6-11 years) |
26.0
13.1%
|
23.4
23.6%
|
| Grade 3 Malaise; Post-Inj. 3 (6-11 years) |
0.0
0%
|
2.1
2.1%
|
| Myalgia; Post-Inj. 3 (6-11 years) |
19.8
9.9%
|
31.9
32.2%
|
| Grade 3 Myalgia; Post-Inj. 3 (6-11 years) |
0.0
0%
|
2.1
2.1%
|
| Asthenia; Post-Inj. 3 (6-11 years) |
15.6
7.8%
|
10.6
10.7%
|
| Grade 3 Asthenia; Post-Inj. 3 (6-11 years) |
0.0
0%
|
0.0
0%
|
| Title | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Dengue parental serotype 1; Pre-Inj. 1 |
29.6
14.9%
|
38.4
38.8%
|
| Dengue parental serotype 1; 28 days Post-Inj. 1 |
55.4
27.8%
|
37.9
38.3%
|
| Dengue parental serotype 1; Pre-Inj. 2 |
42.3
21.3%
|
39.1
39.5%
|
| Dengue parental serotype 1; 28 days Post-Inj. 2 |
98.4
49.4%
|
39.1
39.5%
|
| Dengue parental serotype 1; Pre-Inj. 3 |
74.7
37.5%
|
41.8
42.2%
|
| Dengue parental serotype 1; 28 days Post-Inj. 3 |
98.4
49.4%
|
46.1
46.6%
|
| Dengue parental serotype 2; Pre-Inj. 1 |
17.1
8.6%
|
21.2
21.4%
|
| Dengue parental serotype 2; 28 days Post-Inj. 1 |
40.4
20.3%
|
21.1
21.3%
|
| Dengue parental serotype 2; Pre-Inj. 2 |
32.8
16.5%
|
20.4
20.6%
|
| Dengue parental serotype 2; 28 days Post-Inj. 2 |
68.1
34.2%
|
16.3
16.5%
|
| Dengue parental serotype 2; Pre-Inj. 3 |
35.5
17.8%
|
20.9
21.1%
|
| Dengue parental serotype 2; 28 days Post-Inj. 3 |
79.0
39.7%
|
20.2
20.4%
|
| Dengue parental serotype 3; Pre-Inj. 1 |
30.7
15.4%
|
38.4
38.8%
|
| Dengue parental serotype 3; 28 days Post-Inj.1 |
68.4
34.4%
|
38.9
39.3%
|
| Dengue parental serotype 3; Pre-Inj. 2 |
51.9
26.1%
|
39.8
40.2%
|
| Dengue parental serotype 3; 28 days Post-Inj. 2 |
100.0
50.3%
|
40.2
40.6%
|
| Dengue parental serotype 3; Pre-Inj. 3 |
72.6
36.5%
|
39.6
40%
|
| Dengue parental serotype 3; 28 days Post-Inj. 3 |
98.9
49.7%
|
43.8
44.2%
|
| Dengue parental serotype 4; Pre-Inj. 1 |
14.1
7.1%
|
18.2
18.4%
|
| Dengue parental serotype 4; 28 days Post-Inj. 1 |
74.1
37.2%
|
18.9
19.1%
|
| Dengue parental serotype 4; Pre-Inj. 2 |
57.7
29%
|
20.4
20.6%
|
| Dengue parental serotype 4; 28 days Post-Inj. 2 |
97.9
49.2%
|
19.6
19.8%
|
| Dengue parental serotype 4; Pre-Inj. 3 |
82.8
41.6%
|
18.7
18.9%
|
| Dengue parental serotype 4; 28 days Post-Inj. 3 |
98.9
49.7%
|
23.6
23.8%
|
| Title | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 100 | 50 |
| Dengue parental serotype 1; Pre-Inj. 1 |
30.0
15.1%
|
32.0
32.3%
|
| Dengue parental serotype 1; 28 days Post-Inj. 1 |
54.7
27.5%
|
33.3
33.6%
|
| Dengue parental serotype 1; Pre-Inj. 2 |
38.7
19.4%
|
31.1
31.4%
|
| Dengue parental serotype 1; 28 days Post-Inj. 2 |
97.8
49.1%
|
31.1
31.4%
|
| Dengue parental serotype 1; Pre-Inj. 3 |
72.2
36.3%
|
36.4
36.8%
|
| Dengue parental serotype 1; 28 days Post-Inj. 3 |
98.9
49.7%
|
44.2
44.6%
|
| Dengue parental serotype 2; Pre-Inj. 1 |
14.0
7%
|
16.0
16.2%
|
| Dengue parental serotype 2; 28 days Post-Inj. 1 |
32.6
16.4%
|
16.7
16.9%
|
| Dengue parental serotype 2; Pre-Inj. 2 |
29.0
14.6%
|
15.2
15.4%
|
| Dengue parental serotype 2; 28 days Post-Inj. 2 |
64.1
32.2%
|
11.1
11.2%
|
| Dengue parental serotype 2; Pre-Inj. 3 |
28.9
14.5%
|
18.2
18.4%
|
| Dengue parental serotype 2; 28 days Post-Inj. 3 |
77.8
39.1%
|
20.9
21.1%
|
| Dengue parental serotype 3; Pre-Inj. 1 |
28.0
14.1%
|
32.0
32.3%
|
| Dengue parental serotype 3; 28 days Post-Inj. 1 |
62.1
31.2%
|
35.4
35.8%
|
| Dengue parental serotype 3; Pre-Inj. 2 |
45.2
22.7%
|
32.6
32.9%
|
| Dengue parental serotype 3; 28 days Post-Inj. 2 |
100.0
50.3%
|
33.3
33.6%
|
| Dengue parental serotype 3; Pre-Inj. 3 |
70.0
35.2%
|
34.1
34.4%
|
| Dengue parental serotype 3; 28 days Post-Inj. 3 |
100.0
50.3%
|
39.5
39.9%
|
| Dengue parental serotype 4; Pre-Inj. 1 |
13.0
6.5%
|
18.0
18.2%
|
| Dengue parental serotype 4; 28 days Post-Inj. 1 |
74.7
37.5%
|
22.9
23.1%
|
| Dengue parental serotype 4; Pre-Inj. 2 |
60.2
30.3%
|
17.4
17.6%
|
| Dengue parental serotype 4; 28 days Post-Inj. 2 |
100.0
50.3%
|
20.0
20.2%
|
| Dengue parental serotype 4; Pre-Inj. 3 |
87.8
44.1%
|
22.7
22.9%
|
| Dengue parental serotype 4; 28 days Post-Inj. 3 |
100.0
50.3%
|
27.9
28.2%
|
| Title | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 99 | 49 |
| Dengue parental serotype 1; Pre-Inj. 1 |
29.3
14.7%
|
44.9
45.4%
|
| Dengue parental serotype 1; 28 days Post-Inj. 1 |
56.1
28.2%
|
42.6
43%
|
| Dengue parental serotype 1; Pre-Inj. 2 |
45.8
23%
|
46.8
47.3%
|
| Dengue parental serotype 1; 28 days Post-Inj. 2 |
99.0
49.7%
|
46.8
47.3%
|
| Dengue parental serotype 1; Pre-Inj. 3 |
77.1
38.7%
|
46.8
47.3%
|
| Dengue parental serotype 1; 28 days Post-Inj. 3 |
97.9
49.2%
|
47.8
48.3%
|
| Dengue parental serotype 2; Pre-Inj. 1 |
20.2
10.2%
|
26.5
26.8%
|
| Dengue parental serotype 2; 28 days Post-Inj. 1 |
48.0
24.1%
|
25.5
25.8%
|
| Dengue parental serotype 2; Pre-Inj. 2 |
36.5
18.3%
|
25.5
25.8%
|
| Dengue parental serotype 2; 28 days Post-Inj. 2 |
71.9
36.1%
|
21.3
21.5%
|
| Dengue parental serotype 2; Pre-Inj. 3 |
41.7
21%
|
23.4
23.6%
|
| Dengue parental serotype 2; 28 days Post-Inj. 3 |
80.2
40.3%
|
19.6
19.8%
|
| Dengue parental serotype 3; Pre-Inj. 1 |
33.3
16.7%
|
44.9
45.4%
|
| Dengue parental serotype 3; 28 days Post-Inj 1 |
74.5
37.4%
|
42.6
43%
|
| Dengue parental serotype 3; Pre-Inj. 2 |
58.3
29.3%
|
46.8
47.3%
|
| Dengue parental serotype 3; 28 days Post-Inj. 2 |
100.0
50.3%
|
46.8
47.3%
|
| Dengue parental serotype 3; Pre-Inj. 3 |
75.0
37.7%
|
44.7
45.2%
|
| Dengue parental serotype 3; 28 days Post-Inj. 3 |
97.9
49.2%
|
47.8
48.3%
|
| Dengue parental serotype 4; Pre-Inj. 1 |
15.2
7.6%
|
18.4
18.6%
|
| Dengue parental serotype 4; 28 days Post-Inj. 1 |
73.5
36.9%
|
14.9
15.1%
|
| Dengue parental serotype 4; Pre-Inj. 2 |
55.2
27.7%
|
23.4
23.6%
|
| Dengue parental serotype 4; 28 days Post-Inj. 2 |
95.8
48.1%
|
19.1
19.3%
|
| Dengue parental serotype 4; Pre-Inj. 3 |
78.1
39.2%
|
14.9
15.1%
|
| Dengue parental serotype 4; 28 days Post-Inj. 3 |
97.9
49.2%
|
19.6
19.8%
|
| Title | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Dengue parental serotype 1; Pre-Inj. 1 |
30.6
15.4%
|
36.4
36.8%
|
| Dengue parental serotype 1; 28 days Post-Inj. 2 |
94.7
47.6%
|
39.1
39.5%
|
| Dengue parental serotype 1; 28 days Post-Inj. 3 |
96.2
48.3%
|
48.3
48.8%
|
| Dengue parental serotype 2; Pre-Inj. 1 |
31.5
15.8%
|
41.4
41.8%
|
| Dengue parental serotype 2; 28 days Post-Inj. 2 |
97.9
49.2%
|
43.5
43.9%
|
| Dengue parental serotype 2; 28 days Post-Inj. 3 |
98.4
49.4%
|
47.2
47.7%
|
| Dengue parental serotype 3; Pre-Inj. 1 |
35.0
17.6%
|
46.5
47%
|
| Dengue parental serotype 3; 28 days Post-Inj. 2 |
98.9
49.7%
|
51.1
51.6%
|
| Dengue parental serotype 3; 28 days Post-Inj. 3 |
98.4
49.4%
|
67.4
68.1%
|
| Dengue parental serotype 4; Pre-Inj. 1 |
19.3
9.7%
|
22.2
22.4%
|
| Dengue parental serotype 4; 28 days Post-Inj. 2 |
98.4
49.4%
|
35.9
36.3%
|
| Dengue parental serotype 4; 28 days Post-Inj. 3 |
98.9
49.7%
|
48.3
48.8%
|
| Title | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 100 | 50 |
| Dengue parental serotype 1; Pre-Inj. 1 |
30.3
15.2%
|
30.0
30.3%
|
| Dengue parental serotype 1; 28 days Post-Inj. 2 |
96.7
48.6%
|
31.1
31.4%
|
| Dengue parental serotype 1; 28 days Post-Inj. 3 |
97.8
49.1%
|
41.9
42.3%
|
| Dengue parental serotype 2; Pre-Inj. 1 |
30.3
15.2%
|
38.0
38.4%
|
| Dengue parental serotype 2; 28 days Post-Inj. 2 |
96.7
48.6%
|
37.8
38.2%
|
| Dengue parental serotype 2; 28 days Post-Inj. 3 |
100.0
50.3%
|
44.2
44.6%
|
| Dengue parental serotype 3; Pre-Inj. 1 |
35.4
17.8%
|
38.0
38.4%
|
| Dengue parental serotype 3; 28 days Post-Inj. 2 |
98.9
49.7%
|
53.3
53.8%
|
| Dengue parental serotype 3; 28 days Post-Inj. 3 |
98.9
49.7%
|
65.1
65.8%
|
| Dengue parental serotype 4; Pre-Inj. 1 |
16.2
8.1%
|
22.0
22.2%
|
| Dengue parental serotype 4; 28 days Post-Inj. 2 |
97.8
49.1%
|
35.6
36%
|
| Dengue parental serotype 4; 28 days Post-Inj. 3 |
100.0
50.3%
|
46.5
47%
|
| Title | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 99 | 49 |
| Dengue parental serotype 1; Pre-Inj. 1 |
30.9
15.5%
|
42.9
43.3%
|
| Dengue parental serotype 1; 28 days Post-Inj. 2 |
92.6
46.5%
|
46.8
47.3%
|
| Dengue parental serotype 1; 28 days Post-Inj. 3 |
94.8
47.6%
|
54.3
54.8%
|
| Dengue parental serotype 2; Pre-Inj. 1 |
32.7
16.4%
|
44.9
45.4%
|
| Dengue parental serotype 2; 28 days Post-Inj. 2 |
98.9
49.7%
|
48.9
49.4%
|
| Dengue parental serotype 2; 28 days Post-Inj. 3 |
96.9
48.7%
|
50.0
50.5%
|
| Dengue parental serotype 3; Pre-Inj. 1 |
34.7
17.4%
|
55.1
55.7%
|
| Dengue parental serotype 3; 28 days Post-Inj. 2 |
98.9
49.7%
|
48.9
49.4%
|
| Dengue parental serotype 3; 28 days Post-Inj. 3 |
97.9
49.2%
|
69.6
70.3%
|
| Dengue parental serotype 4; Pre-Inj. 1 |
22.4
11.3%
|
22.4
22.6%
|
| Dengue parental serotype 4; 28 days Post-Inj. 2 |
98.9
49.7%
|
36.2
36.6%
|
| Dengue parental serotype 4; 28 days Post-Inj. 3 |
97.9
49.2%
|
50.0
50.5%
|
| Title | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| At least 1 positive serotype; Pre-Inj. 1 |
32.2
16.2%
|
40.4
40.8%
|
| At least 1 positive serotype; 28 days Post-Inj. 1 |
80.8
40.6%
|
40.0
40.4%
|
| At least 1 positive serotype; Pre-Inj. 2 |
69.8
35.1%
|
40.9
41.3%
|
| At least 1 positive serotype; 28 days Post-Inj. 2 |
100.0
50.3%
|
42.4
42.8%
|
| At least 1 positive serotype; Pre-Inj. 3 |
88.7
44.6%
|
42.9
43.3%
|
| At least 1 positive serotype; 28 days Post-Inj. 3 |
98.9
49.7%
|
48.3
48.8%
|
| At least 2 positive serotypes; Pre-Inj. 1 |
29.1
14.6%
|
38.4
38.8%
|
| At least 2 positive serotypes; 28 days Post-Inj. 1 |
66.8
33.6%
|
38.9
39.3%
|
| At least 2 positive serotypes; Pre-Inj. 2 |
49.2
24.7%
|
39.8
40.2%
|
| At least 2 positive serotypes; 28 days Post-Inj. 2 |
100.0
50.3%
|
40.2
40.6%
|
| At least 2 positive serotypes; Pre-Inj. 3 |
75.3
37.8%
|
39.6
40%
|
| At least 2 positive serotypes; 28 days Post-Inj. 3 |
98.9
49.7%
|
43.8
44.2%
|
| At least 3 positive serotypes; Pre-Inj. 1 |
19.6
9.8%
|
24.2
24.4%
|
| At least 3 positive serotypes; 28 days Post-Inj. 1 |
52.8
26.5%
|
25.3
25.6%
|
| At least 3 positive serotypes; Pre-Inj. 2 |
38.1
19.1%
|
22.6
22.8%
|
| At least 3 positive serotypes; 28 days Post-Inj. 2 |
98.4
49.4%
|
21.7
21.9%
|
| At least 3 positive serotypes; Pre-Inj. 3 |
67.7
34%
|
25.3
25.6%
|
| At least 3 positive serotypes; 28 days Post-Inj. 3 |
98.4
49.4%
|
25.8
26.1%
|
| All 4 positive serotypes; Pre-Inj. 1 |
10.6
5.3%
|
13.1
13.2%
|
| All 4 positive serotypes; 28 days Post-Inj. 1 |
37.8
19%
|
12.6
12.7%
|
| All 4 positive serotypes; Pre-Inj. 2 |
27.5
13.8%
|
16.1
16.3%
|
| All 4 positive serotypes; 28 days Post-Inj. 2 |
66.0
33.2%
|
10.9
11%
|
| All 4 positive serotypes; Pre-Inj. 3 |
33.9
17%
|
13.2
13.3%
|
| All 4 positive serotypes; 28 days Post-Inj. 3 |
79.0
39.7%
|
15.7
15.9%
|
| Title | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 100 | 50 |
| At least 1 positive serotype; Pre-Inj. 1 |
31.0
15.6%
|
34.0
34.3%
|
| At least 1 positive serotype; 28 days Post-Inj. 1 |
78.9
39.6%
|
35.4
35.8%
|
| At least 1 positive serotype; Pre-Inj. 2 |
67.7
34%
|
32.6
32.9%
|
| At least 1 positive serotype; 28 days Post-Inj. 2 |
100.0
50.3%
|
33.3
33.6%
|
| At least 1 positive serotype; Pre-Inj. 3 |
90.0
45.2%
|
36.4
36.8%
|
| At least 1 positive serotype; 28 days Post-Inj. 3 |
100.0
50.3%
|
44.2
44.6%
|
| At least 2 positive serotypes; Pre-Inj. 1 |
28.0
14.1%
|
32.0
32.3%
|
| At least 2 positive serotypes; 28 days Post-Inj. 1 |
65.3
32.8%
|
35.4
35.8%
|
| At least 2 positive serotypes; Pre-Inj. 2 |
46.2
23.2%
|
32.6
32.9%
|
| At least 2 positive serotypes; 28 days Post-Inj. 2 |
100.0
50.3%
|
33.3
33.6%
|
| At least 2 positive serotypes; Pre-Inj. 3 |
75.6
38%
|
34.1
34.4%
|
| At least 2 positive serotypes; 28 days Post-Inj. 3 |
100.0
50.3%
|
39.5
39.9%
|
| At least 3 positive serotypes; Pre-Inj. 1 |
17.0
8.5%
|
24.0
24.2%
|
| At least 3 positive serotypes; 28 days Post-Inj. 1 |
48.4
24.3%
|
27.1
27.4%
|
| At least 3 positive serotypes; Pre-Inj. 2 |
33.3
16.7%
|
19.6
19.8%
|
| At least 3 positive serotypes; 28 days Post-Inj. 2 |
98.9
49.7%
|
20.0
20.2%
|
| At least 3 positive serotypes; Pre-Inj. 3 |
65.6
33%
|
27.3
27.6%
|
| At least 3 positive serotypes; 28 days Post-Inj. 3 |
98.9
49.7%
|
30.2
30.5%
|
| All 4 positive serotypes; Pre-Inj. 1 |
9.0
4.5%
|
8.0
8.1%
|
| All 4 positive serotypes; 28 days Post-Inj. 1 |
31.6
15.9%
|
10.4
10.5%
|
| All 4 positive serotypes; Pre-Inj. 2 |
25.8
13%
|
10.9
11%
|
| All 4 positive serotypes; 28 days Post-Inj. 2 |
63.0
31.7%
|
8.9
9%
|
| All 4 positive serotypes; Pre-Inj. 3 |
27.8
14%
|
13.6
13.7%
|
| All 4 positive serotypes; 28 days Post-Inj. 3 |
77.8
39.1%
|
18.6
18.8%
|
| Title | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine |
|---|---|
| Description | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 99 | 49 |
| At least 1 positive serotype; Pre-Inj. 1 |
33.3
16.7%
|
46.9
47.4%
|
| At least 1 positive serotype; 28 days Post-Inj. 1 |
82.7
41.6%
|
44.7
45.2%
|
| At least 1 positive serotype; Pre-Inj. 2 |
71.9
36.1%
|
48.9
49.4%
|
| At least 1 positive serotype; 28 days Post-Inj. 2 |
100.0
50.3%
|
51.1
51.6%
|
| At least 1 positive serotype; Pre-Inj. 3 |
87.5
44%
|
48.9
49.4%
|
| At least 1 positive serotype; 28 days Post-Inj. 3 |
97.9
49.2%
|
52.2
52.7%
|
| At least 2 positive serotypes; Pre-Inj. 1 |
30.3
15.2%
|
44.9
45.4%
|
| At least 2 positive serotypes; 28 days Post-Inj. 1 |
68.4
34.4%
|
42.6
43%
|
| At least 2 positive serotypes; Pre-Inj. 2 |
52.1
26.2%
|
46.8
47.3%
|
| At least 2 positive serotypes; 28 days Post-Inj. 2 |
100.0
50.3%
|
46.8
47.3%
|
| At least 2 positive serotypes; Pre-Inj. 3 |
75.0
37.7%
|
44.7
45.2%
|
| At least 2 positive serotypes; 28 days Post-Inj. 3 |
97.9
49.2%
|
47.8
48.3%
|
| At least 3 positive serotypes; Pre-Inj. 1 |
22.2
11.2%
|
24.5
24.7%
|
| At least 3 positive serotypes; 28 days Post-Inj. 1 |
57.1
28.7%
|
23.4
23.6%
|
| At least 3 positive serotypes; Pre-Inj. 2 |
42.7
21.5%
|
25.5
25.8%
|
| At least 3 positive serotypes; 28 days Post-Inj. 2 |
97.9
49.2%
|
23.4
23.6%
|
| At least 3 positive serotypes; Pre-Inj. 3 |
69.8
35.1%
|
23.4
23.6%
|
| At least 3 positive serotypes; 28 days Post-Inj. 3 |
97.9
49.2%
|
21.7
21.9%
|
| All 4 positive serotypes; Pre-Inj. 1 |
12.1
6.1%
|
18.4
18.6%
|
| All 4 positive serotypes; 28 days Post-Inj. 1 |
43.9
22.1%
|
14.9
15.1%
|
| All 4 positive serotypes; Pre-Inj. 2 |
29.2
14.7%
|
21.3
21.5%
|
| All 4 positive serotypes; 28 days Post-Inj. 2 |
68.8
34.6%
|
12.8
12.9%
|
| All 4 positive serotypes; Pre-Inj. 3 |
39.6
19.9%
|
12.8
12.9%
|
| All 4 positive serotypes; 28 days Post-Inj. 3 |
80.2
40.3%
|
13.0
13.1%
|
| Title | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine |
|---|---|
| Description | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| At least 1 positive serotype; Pre-Inj. 1 |
37.6
18.9%
|
48.5
49%
|
| At least 1 positive serotype; 28 days Post-Inj. 2 |
100.0
50.3%
|
57.6
58.2%
|
| At least 1 positive serotype; 28 days Post-Inj. 3 |
99.5
50%
|
73.0
73.7%
|
| At least 2 positive serotypes; Pre-Inj. 1 |
31.5
15.8%
|
41.4
41.8%
|
| At least 2 positive serotypes; 28 days Post-Inj. 2 |
99.5
50%
|
41.3
41.7%
|
| At least 2 positive serotypes; 28 days Post-Inj. 3 |
99.5
50%
|
52.8
53.3%
|
| At least 3 positive serotypes; Pre-Inj. 1 |
29.9
15%
|
37.4
37.8%
|
| At least 3 positive serotypes; 28 days Post-Inj. 2 |
98.4
49.4%
|
41.3
41.7%
|
| At least 3 positive serotypes; 28 days Post-Inj. 3 |
98.4
49.4%
|
46.1
46.6%
|
| All 4 positive serotypes; Pre-Inj. 1 |
17.3
8.7%
|
19.2
19.4%
|
| All 4 positive serotypes; 28 days Post-Inj. 2 |
90.9
45.7%
|
29.3
29.6%
|
| All 4 positive serotypes; 28 days Post-Inj. 3 |
94.1
47.3%
|
39.3
39.7%
|
| Title | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine |
|---|---|
| Description | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 100 | 50 |
| At least 1 positive serotype; Pre-Inj. 1 |
39.4
19.8%
|
42.0
42.4%
|
| At least 1 positive serotype; 28 days Post-Inj. 2 |
100.0
50.3%
|
64.4
65.1%
|
| At least 1 positive serotype; 28 days Post-Inj. 3 |
100.0
50.3%
|
74.4
75.2%
|
| At least 2 positive serotypes; Pre-Inj. 1 |
30.3
15.2%
|
36.0
36.4%
|
| At least 2 positive serotypes; 28 days Post-Inj. 2 |
100.0
50.3%
|
33.3
33.6%
|
| At least 2 positive serotypes; 28 days Post-Inj. 3 |
100.0
50.3%
|
44.2
44.6%
|
| At least 3 positive serotypes; Pre-Inj. 1 |
28.3
14.2%
|
34.0
34.3%
|
| At least 3 positive serotypes; 28 days Post-Inj. 2 |
97.8
49.1%
|
33.3
33.6%
|
| At least 3 positive serotypes; 28 days Post-Inj. 3 |
100
50.3%
|
41.9
42.3%
|
| All 4 positive serotypes; Pre-Inj. 1 |
14.1
7.1%
|
16.0
16.2%
|
| All 4 positive serotypes; 28 days Post-Inj. 2 |
90.2
45.3%
|
26.7
27%
|
| All 4 positive serotypes; 28 days Post-Inj. 3 |
96.7
48.6%
|
37.2
37.6%
|
| Title | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine |
|---|---|
| Description | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 99 | 49 |
| At least 1 positive serotype; Pre-Inj. 1 |
35.7
17.9%
|
55.1
55.7%
|
| At least 1 positive serotype; 28 days Post-Inj. 2 |
100.0
50.3%
|
51.1
51.6%
|
| At least 1 positive serotype; 28 days Post-Inj. 3 |
99.0
49.7%
|
71.7
72.4%
|
| At least 2 positive serotypes; Pre-Inj. 1 |
32.7
16.4%
|
46.9
47.4%
|
| At least 2 positive serotypes; 28 days Post-Inj. 2 |
98.9
49.7%
|
48.9
49.4%
|
| At least 2 positive serotypes; 28 days Post-Inj. 3 |
99.0
49.7%
|
60.9
61.5%
|
| At least 3 positive serotypes; Pre-Inj. 1 |
31.6
15.9%
|
40.8
41.2%
|
| At least 3 positive serotypes; 28 days Post-Inj. 2 |
98.9
49.7%
|
48.9
49.4%
|
| At least 3 positive serotypes; 28 days Post-Inj. 3 |
96.9
48.7%
|
50.0
50.5%
|
| All 4 positive serotypes; Pre-Inj. 1 |
20.4
10.3%
|
22.4
22.6%
|
| All 4 positive serotypes; 28 days Post-Inj. 2 |
91.6
46%
|
31.9
32.2%
|
| All 4 positive serotypes; 28 days Post-Inj. 3 |
91.7
46.1%
|
41.3
41.7%
|
| Title | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Serotype 1; Pre-Inj. 1, All |
17.4
|
22.8
|
| Serotype 1; 28 days Post-Inj. 2, All |
125
|
26.4
|
| Serotype 1; 28 days Post-Inj. 3, All |
179
|
38.1
|
| Serotype 2; Pre-Inj. 1, All |
14.4
|
18.2
|
| Serotype 2; 28 days Post-Inj. 2, All |
151
|
17.3
|
| Serotype 2; 28 days Post-Inj. 3, All |
178
|
21.6
|
| Serotype 3; Pre-Inj. 1, All |
16.4
|
21.8
|
| Serotype 3; 28 days Post-Inj. 2, All |
155
|
26.6
|
| Serotype 3; 28 days Post-Inj. 3, All |
190
|
36.2
|
| Serotype 4; Pre-Inj. 1, All |
8.12
|
8.94
|
| Serotype 4; 28 days Post-Inj. 2, All |
144
|
12.8
|
| Serotype 4; 28 days Post-Inj. 3, All |
184
|
16.7
|
| Serotype 1; Pre-Inj. 1, 2-5 years |
16.4
|
16.2
|
| Serotype 1; 28 days Post-Inj. 2, 2-5 years |
135
|
19.0
|
| Serotype 1; 28 days Post-Inj. 3, 2-5 years |
205
|
31.3
|
| Serotype 2; Pre-Inj. 1, 2-5 years |
11.8
|
13.9
|
| Serotype 2; 28 days Post-Inj. 2, 2-5 years |
135
|
13.2
|
| Serotype 2; 28 days Post-Inj. 3, 2-5 years |
195
|
21.8
|
| Serotype 3; Pre-Inj. 1, 2-5 years |
16.2
|
16.7
|
| Serotype 3; 28 days Post-Inj. 2, 2-5 years |
171
|
26.5
|
| Serotype 3; 28 days Post-Inj. 3, 2-5 years |
214
|
35.0
|
| Serotype 4; Pre-Inj. 1, 2-5 years |
7.76
|
9.02
|
| Serotype 4; 28 days Post-Inj. 2, 2-5 years |
165
|
14.4
|
| Serotype 4; 28 days Post-Inj. 3, 2-5 years |
223
|
18.7
|
| Serotype 1; Pre-Inj. 1, 6-11 years |
18.4
|
32.3
|
| Serotype 1; 28 days Post-Inj. 2, 6-11 years |
116
|
36.2
|
| Serotype 1; 28 days Post-Inj. 3, 6-11 years |
157
|
45.8
|
| Serotype 2; Pre-Inj. 1, 6-11 years |
17.5
|
24.0
|
| Serotype 2; 28 days Post-Inj. 2, 6-11 years |
168
|
22.3
|
| Serotype 2; 28 days Post-Inj. 3, 6-11 years |
163
|
21.4
|
| Serotype 3; Pre-Inj. 1, 6-11 years |
16.6
|
28.6
|
| Serotype 3; 28 days Post-Inj. 2, 6-11 years |
141
|
26.6
|
| Serotype 3; 28 days Post-Inj. 3, 6-11 years |
171
|
37.3
|
| Serotype 4; Pre-Inj. 1, 6-11 years |
8.50
|
8.87
|
| Serotype 4; 28 days Post-Inj. 2, 6-11 years |
127
|
11.4
|
| Serotype 4; 28 days Post-Inj. 3, 6-11 years |
152
|
15.0
|
| Title | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Pre-Inj. 1; All participants |
81.4
40.9%
|
83.8
84.6%
|
| 28 days Post-Inj. 1; All participants |
86.5
43.5%
|
83.2
84%
|
| Pre-Inj. 1; 2-5 years |
68.0
34.2%
|
74.0
74.7%
|
| 28 days Post-Inj. 1; 2-5 years |
76.6
38.5%
|
72.9
73.6%
|
| Pre-Inj. 1; 6-11 years |
94.9
47.7%
|
93.9
94.8%
|
| 28 days Post-Inj. 1; 6-11 years |
95.9
48.2%
|
93.6
94.5%
|
| Title | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| Time Frame | Pre-Injection 1 and 28 days Post-Injection 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Pre-Inj. 1; All participants |
32.3
|
36.0
|
| 28 days Post-Inj. 1; All participants |
43.7
|
36.0
|
| Pre-Inj. 1; 2-5 years |
15.9
|
20.5
|
| 28 days Post-Inj. 1; 2-5 years |
22.4
|
21.2
|
| Pre-Inj. 1; 6-11 years |
66.1
|
63.9
|
| 28 days Post-Inj. 1; 6-11 years |
82.9
|
61.8
|
| Title | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo |
|---|---|
| Description | GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| Time Frame | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category. |
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group |
|---|---|---|
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Measure Participants | 199 | 99 |
| Serotype 1; Pre-Inj. 1, All |
18.8
|
23.9
|
| Serotype 1; 28 days Post-Inj.1, All |
43.1
|
22.8
|
| Serotype 1; Pre-Inj. 2, All |
29.2
|
26.0
|
| Serotype 1; 28 days Post-Inj. 2, All |
214
|
26.1
|
| Serotype 1; Pre-Inj. 3, All |
64.1
|
28.9
|
| Serotype 1; 28 days Post-Inj. 3, All |
254
|
35.3
|
| Serotype 2; Pre-Inj. 1, All |
7.55
|
7.76
|
| Serotype 2; 28 days Post-Inj.1, All |
15.5
|
7.51
|
| Serotype 2; Pre-Inj. 2, All |
11.6
|
7.32
|
| Serotype 2; 28 days Post-Inj. 2, All |
21.4
|
6.99
|
| Serotype 2; Pre-Inj. 3, All |
11.4
|
7.26
|
| Serotype 2; 28 days Post-Inj. 3, All |
22.3
|
7.73
|
| Serotype 3; Pre-Inj. 1, All |
13.1
|
16.3
|
| Serotype 3; 28 days Post-Inj.1, All |
41.4
|
15.3
|
| Serotype 3; Pre-Inj. 2, All |
22.6
|
15.4
|
| Serotype 3; 28 days Post-Inj. 2, All |
128
|
15.5
|
| Serotype 3; Pre-Inj. 3, All |
31.0
|
14.0
|
| Serotype 3; 28 days Post-Inj. 3, All |
99.2
|
16.0
|
| Serotype 4; Pre-Inj. 1, All |
7.52
|
8.08
|
| Serotype 4; 28 days Post-Inj.1, All |
87.9
|
7.84
|
| Serotype 4; Pre-Inj. 2, All |
21.3
|
7.73
|
| Serotype 4; 28 days Post-Inj. 2, All |
158
|
7.81
|
| Serotype 4; Pre-Inj. 3, All |
39.2
|
7.49
|
| Serotype 4; 28 days Post-Inj. 3, All |
147
|
8.54
|
| Serotype 1; Pre-Inj. 1, 2-5 years |
20.3
|
18.6
|
| Serotype 1; 28 days Post-Inj. 1, 2-5 years |
44.8
|
19.6
|
| Serotype 1; Pre-Inj. 2, 2-5 years |
31.3
|
19.7
|
| Serotype 1; 28 days Post-Inj. 2, 2-5 years |
281
|
20.9
|
| Serotype 1; Pre-Inj. 3, 2-5 years |
65.2
|
22.1
|
| Serotype 1; 28 days Post-Inj. 3, 2-5 years |
315
|
35.9
|
| Serotype 2; Pre-Inj. 1, 2-5 years |
6.66
|
6.48
|
| Serotype 2; 28 days Post-Inj. 1, 2-5 years |
12.7
|
6.73
|
| Serotype 2; Pre-Inj. 2, 2-5 years |
10.1
|
6.28
|
| Serotype 2; 28 days Post-Inj. 2, 2-5 years |
17.1
|
6.13
|
| Serotype 2; Pre-Inj. 3, 2-5 years |
9.03
|
6.68
|
| Serotype 2; 28 days Post-Inj. 3, 2-5 years |
19.7
|
7.93
|
| Serotype 3; Pre-Inj. 1, 2-5 years |
11.8
|
12.2
|
| Serotype 3; 28 days Post-Inj. 1, 2-5 years |
37.4
|
12.9
|
| Serotype 3; Pre-Inj. 2, 2-5 years |
19.8
|
12.3
|
| Serotype 3; 28 days Post-Inj. 2, 2-5 years |
129
|
12.6
|
| Serotype 3; Pre-Inj. 3, 2-5 years |
26.7
|
12.2
|
| Serotype 3; 28 days Post-Inj. 3, 2-5 years |
108
|
15.3
|
| Serotype 4; Pre-Inj. 1, 2-5 years |
7.04
|
7.74
|
| Serotype 4; 28 days Post-Inj. 1, 2-5 years |
114
|
8.43
|
| Serotype 4; Pre-Inj. 2, 2-5 years |
22.3
|
7.64
|
| Serotype 4; 28 days Post-Inj. 2, 2-5 years |
200
|
8.22
|
| Serotype 4; Pre-Inj. 3, 2-5 years |
39.4
|
7.97
|
| Serotype 4; 28 days Post-Inj. 3, 2-5 years |
176
|
9.37
|
| Serotype 1; Pre-Inj. 1, 6-11 years |
17.4
|
31.0
|
| Serotype 1; 28 days Post-Inj. 1, 6-11 years |
41.5
|
26.7
|
| Serotype 1; Pre-Inj. 2, 6-11 years |
27.4
|
33.9
|
| Serotype 1; 28 days Post-Inj. 2, 6-11 years |
165
|
32.4
|
| Serotype 1; Pre-Inj. 3, 6-11 years |
63.2
|
37.2
|
| Serotype 1;28 days Post-Inj. 3, 6-11 years |
207
|
34.7
|
| Serotype 2; Pre-Inj. 1, 6-11 years |
8.57
|
9.32
|
| Serotype 2; 28 days Post-Inj. 1, 6-11 years |
18.8
|
8.40
|
| Serotype 2; Pre-Inj. 2, 6-11 years |
13.3
|
8.50
|
| Serotype 2; 28 days Post-Inj. 2, 6-11 years |
26.5
|
7.92
|
| Serotype 2; Pre-Inj. 3, 6-11 years |
14.1
|
7.85
|
| Serotype 2; 28 days Post-Inj. 3, 6-11 years |
25.0
|
7.55
|
| Serotype 3; Pre-Inj. 1, 6-11 years |
14.4
|
21.8
|
| Serotype 3; 28 days Post-Inj. 1, 6-11 years |
45.6
|
18.3
|
| Serotype 3; Pre-Inj. 2, 6-11 years |
25.6
|
19.2
|
| Serotype 3; 28 days Post-Inj. 2, 6-11 years |
126
|
19.1
|
| Serotype 3; Pre-Inj. 3, 6-11 years |
35.6
|
15.8
|
| Serotype 3; 28 days Post-Inj. 3, 6-11 years |
91.3
|
16.7
|
| Serotype 4; Pre-Inj. 1, 6-11 years |
8.03
|
8.43
|
| Serotype 4; 28 days Post-Inj. 1, 6-11 years |
68.2
|
7.28
|
| Serotype 4; Pre-Inj. 2, 6-11 years |
20.3
|
7.82
|
| Serotype 4; 28 days Post-Inj. 2, 6-11 years |
126
|
7.44
|
| Serotype 4; Pre-Inj. 3, 6-11 years |
39.0
|
7.06
|
| Serotype 4; 28 days Post-Inj. 3, 6-11 years |
125
|
7.82
|
Adverse Events
| Time Frame | Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination. | |||
| Arm/Group Title | CYD Dengue Vaccine Group | Control Group | ||
| Arm/Group Description | Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). | ||
All Cause Mortality |
||||
| CYD Dengue Vaccine Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/199 (0%) | 0/99 (0%) | ||
Serious Adverse Events |
||||
| CYD Dengue Vaccine Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/199 (1%) | 4/99 (4%) | ||
| Gastrointestinal disorders | ||||
| Food poisoning | 0/199 (0%) | 0 | 1/99 (1%) | 1 |
| Inguinal hernia | 0/199 (0%) | 0 | 1/99 (1%) | 2 |
| Infections and infestations | ||||
| Gastrointestinal infection | 0/199 (0%) | 0 | 1/99 (1%) | 1 |
| Pneumonia | 0/199 (0%) | 0 | 1/99 (1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Epiphyseal disorder | 1/199 (0.5%) | 1 | 0/99 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Vascular purpura | 1/199 (0.5%) | 1 | 0/99 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| CYD Dengue Vaccine Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 71/199 (35.7%) | 29/99 (29.3%) | ||
| General disorders | ||||
| Injection site Pain; Post-injection 1, All participants | 41/199 (20.6%) | 41 | 17/99 (17.2%) | 17 |
| Injection site Erythema; Post-injection 1, All participants | 15/199 (7.5%) | 15 | 4/99 (4%) | 4 |
| Injection site Swelling; Post-injection 1, all participants | 11/199 (5.5%) | 11 | 5/99 (5.1%) | 5 |
| Injection site Pain; Post-injection 2, All participants | 37/188 (19.7%) | 37 | 16/92 (17.4%) | 16 |
| Injection site Pain; Post-injection 3, All participants | 33/186 (17.7%) | 33 | 29/90 (32.2%) | 29 |
| Injection site Erythema; Post-injection 3, All participants | 8/186 (4.3%) | 8 | 10/90 (11.1%) | 10 |
| Injection site Swelling; Post-injection 3, All participants | 6/186 (3.2%) | 6 | 8/90 (8.9%) | 8 |
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 participant 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 | Director |
|---|---|
| Organization | Sanofi Pasteur SA |
| Phone | |
| Contact-US@sanofi.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00788151
Other Study ID Numbers:
- CYD24
- 2014-001711-40
First Posted:
Nov 10, 2008
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022