Trial · NCT01983553
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
NCT01983553, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2019-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study. Trials, record NCT01983553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01983553
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
- NCT number
- NCT01983553
- Status
- Completed
- Enrollment
- 3,203 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- First posted
- 2013-11-14
- Last updated
- 2022-03-29
- Results first posted
- 2019-07-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. |
| Primary | Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Cases were defined as the number of participants with at least one hospitalized VCD episode. |
| Primary | Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Episodes were defined as the number of hospitalized VCD episodes. |
| Primary | Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values \<0.1 were rounded to 0.1. |
| Primary | Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Cases were defined as the number of participants with at least one hospitalized VCD episode. |
| Primary | Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Episodes were defined as the number of hospitalized VCD episodes. |
| Primary | Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Event rate per 100 participant-years for Clinically Severe hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values \<0.1 were rounded to 0.1. |
| Primary | Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Cases were defined as the number of participants with at least one hospitalized VCD episode. |
| Primary | Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Episodes were defined as the number of hospitalized VCD episodes. |
| Primary | Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23) | During Year 1 to Year 4 post 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sera sample collection time interval of 14 days | Cases were defined as the number of participants with at least one non-serotype specific dengue viremia among hospitalized VCD cases. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. | Events per 100 participant-years | NUMBER |
| PRIMARY | Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. | Cases | NUMBER |
| PRIMARY | Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. | Episodes | NUMBER |
| PRIMARY | Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. Here, number analyzed signifies participants with available data for each specified category. | Events per 100 participant-years | NUMBER |
| PRIMARY | Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. Here, number analyzed signifies participants with evaluable data for each specified category. | Cases | NUMBER |
| PRIMARY | Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. Here, number analyzed signifies participants with evaluable data for each specified category. | Episodes | NUMBER |
| PRIMARY | Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. | Events per 100 participant-years | NUMBER |
| PRIMARY | Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. | Cases | NUMBER |
| PRIMARY | Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 | Analysis was performed on FupAS. | Episodes | NUMBER |
| PRIMARY | Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23) | During Year 1 to Year 4 post 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sera sample collection time interval of 14 days | Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group344
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | CYD Dengue Vaccine Group | Any of the 4 Serotypes | 1.0 | 95% Confidence Interval 0.8 to 1.2 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Control Group | Any of the 4 Serotypes | 1.1 | 95% Confidence Interval 0.8 to 1.4 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | CYD Dengue Vaccine Group | Serotype 1 | 0.2 | 95% Confidence Interval 0.2 to 0.4 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Control Group | Serotype 1 | 0.3 | 95% Confidence Interval 0.1 to 0.5 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | CYD Dengue Vaccine Group | Serotype 2 | 0.3 | 95% Confidence Interval 0.2 to 0.5 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Control Group | Serotype 2 | 0.3 | 95% Confidence Interval 0.1 to 0.5 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | CYD Dengue Vaccine Group | Serotype 3 | 0.2 | 95% Confidence Interval 0.2 to 0.4 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Control Group | Serotype 3 | 0.2 | 95% Confidence Interval 0.1 to 0.4 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | CYD Dengue Vaccine Group | Serotype 4 | 0.2 | 95% Confidence Interval 0.1 to 0.3 | Events per 100 participant-years |
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23) | Control Group | Serotype 4 | 0.3 | 95% Confidence Interval 0.1 to 0.5 | Events per 100 participant-years |
1 to 10 of 344Source ClinicalTrials.gov
See all 344 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CYD Dengue Vaccine Group | 2,131 | |
| Overall Study | STARTED | Control Group | 1,072 | |
| Overall Study | COMPLETED | CYD Dengue Vaccine Group | 2,131 | |
| Overall Study | COMPLETED | Control Group | 1,072 | |
| Overall Study | NOT COMPLETED | CYD Dengue Vaccine Group | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Gun-shot wound | Injury, poisoning and procedural complications | CYD Dengue Vaccine Group | 2 | 2,131 | 2 |
| serious | Gun-shot wound | Injury, poisoning and procedural complications | Control Group | 0 | 1,072 | 0 |
| serious | Road traffic accident | Injury, poisoning and procedural complications | CYD Dengue Vaccine Group | 1 | 2,131 | 1 |
| serious | Road traffic accident | Injury, poisoning and procedural complications | Control Group | 1 | 1,072 | 1 |
| serious | Drowning | General disorders | CYD Dengue Vaccine Group | 0 | 2,131 | 0 |
| serious | Drowning | General disorders | Control Group | 1 | 1,072 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CYD Dengue Vaccine Group | 3 | 2,131 |
| Total, all-cause mortality | Control Group | 2 | 1,072 |
| Total, other adverse events | CYD Dengue Vaccine Group | 0 | 0 |
| Total, other adverse events | Control Group | 0 | 0 |
| Total, serious adverse events | CYD Dengue Vaccine Group | 3 | 2,131 |
| Total, serious adverse events | Control Group | 2 | 1,072 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CYD Dengue Vaccine Group vs Control Group: deaths from any cause | Trial comparisons |
| CYD Dengue Vaccine Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01983553
GET https://conductscience.org/api/trials/v1/NCT01983553/results?page=2