Trial · NCT00842530
Efficacy and Safety of Dengue Vaccine in Healthy Children
NCT00842530, Phase 2, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2019-07-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Dengue Vaccine in Healthy Children. Trials, record NCT00842530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00842530
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Dengue Vaccine in Healthy Children
- NCT number
- NCT00842530
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4,002 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
- Interventions
- CYD Dengue Vaccine, Inactivated rabies virus vaccine, Placebo
- First posted
- 2009-02-12
- Last updated
- 2022-04-05
- Other registries' IDs
- eudract:2014-001710-25
- Results first posted
- 2019-07-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5 degree Celsius (°C) measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue non-structural protein-1 (NS1) enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
| Secondary | Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months) | The severity of VCD cases was assessed by WHO 1999 severity assessment and IDMC clinical assessment. Dengue Hemorrhagic Fever (DHF) Grade I, II, III, and IV : Clinical Manifestations: a) Fever: acute onset, high and continuous, lasting 2-7 days, b) Any of hemorrhagic manifestations: petechiae, purpura, ecchymosis, epistaxis, gum bleeding, and hematemesis and/or melena, c) thrombocytopenia (platelet count=100 000/mm3 or less) d) Plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion and/or hypoalbuminemia. IDMC severity criteria: 1) Thrombocytopenia: platelet count \<= 50 000/mm\^3; 2) Hemorrhage that needs blood transfusion; 3) Objective evidence of capillary permeability 4) Signs of circulatory failure; 5) Visceral Manifestations. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
| Secondary | Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 2 up to Inj. 3, 28 days Post-Inj. 2 up to end of Active Phase ( up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by dengue reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
| Secondary | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | GMT of antibodies against each serotype with the parental dengue virus strain were assessed by the plaque reduction neutralization test (PRNT). |
| Secondary | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue immune participants were defined as those participants with titers \>= 10 (1/dilution) against at least one dengue serotype at baseline. |
| Secondary | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue non-immune participants were defined as participants with titers \< 10 (1/dilution) against all four dengue serotypes at baseline. |
| Secondary | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 7 days post-any Inj. and each of the 3 Inj. | Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain: - Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: - Grade 1: \> 0.0 to \< 2.5 cm, Grade 2: \>= 2.5 to \< 5 cm, Grade 3: \>= 5 cm. |
| Secondary | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 14 days post-any Inj. and each of the 3 Inj. | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5°C to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. Headache, malaise, myalgia and asthenia: - Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities. |
| Other | Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active phase (up to 25 months); 28 days post-Inj. 1 up to end of Active phase (up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>=37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
| Other | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | After 28 days Post Inj. 3 up to the end of Active Phase (up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. VCD cases confirmed only by NS1 method were classified in the Not Identified category. Cases were defined as the number of participants with at least one symptomatic VCD episode more than 28 days after Inj. 3 (during the Active Phase). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months) | Analysis was performed on Per-protocol analysis (PPA) set for efficacy which included participants with no protocol deviations. Participants with following protocol deviations were excluded: inclusion criteria not met or exclusion criteria met, randomization error, Inj. not performed, code breaking and delay between the inj. not respected. | Cases | NUMBER |
| SECONDARY | Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months) | Analysis was performed on PPA set for efficacy. | Cases | NUMBER |
| SECONDARY | Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 2 up to Inj. 3, 28 days Post-Inj. 2 up to end of Active Phase ( up to 25 months) | Analysis was performed on Other Efficacy Analysis Set 2 which included all participants who received at least the two first injections. | Cases | NUMBER |
| SECONDARY | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | Analysis was performed on Full Analysis Set for Immunogenicity defined as the participants included in the subgroup for Immunogenicity assessment who have received at least one dose and who had a blood sample drawn after vaccination. Here, 'number analyzed' = participants with available data for each specified category. | Titers (1/dilution) | GEOMETRIC_MEAN |
| SECONDARY | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | Analysis was performed on Full Analysis Set for Immunogenicity. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Titers (1/dilution) | GEOMETRIC_MEAN |
| SECONDARY | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | Analysis was performed on Full Analysis Set for Immunogenicity. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Titers (1/dilution) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 7 days post-any Inj. and each of the 3 Inj. | Analysis was performed in the Reactogenicity Analysis Set, which included all participants who received at least one injection and were considered evaluable for reactogenicity. Here, 'number analyzed' = participants with available data for each specified category. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 14 days post-any Inj. and each of the 3 Inj. | Analysis was performed on Reactogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active phase (up to 25 months); 28 days post-Inj. 1 up to end of Active phase (up to 25 months) | Analysis was performed on Other Efficacy Analysis Set 1 which included participants who received at least the first injection. | Cases | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | After 28 days Post Inj. 3 up to the end of Active Phase (up to 25 months) | Analysis was performed on Other Efficacy Analysis Set 1. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group330
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | CYD Dengue Vaccine Group | 45 | Cases | ||
| Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Control Group | 32 | Cases | ||
| Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | CYD Dengue Vaccine Group | Severe VCD cases (IDMC clinical assessment) | 1 | Cases | |
| Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Control Group | Severe VCD cases (IDMC clinical assessment) | 2 | Cases | |
| Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | CYD Dengue Vaccine Group | Severe VCD cases (WHO 1999 severity assessment) | 2 | Cases | |
| Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Control Group | Severe VCD cases (WHO 1999 severity assessment) | 2 | Cases | |
| Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | CYD Dengue Vaccine Group | Cases: 28 days Post-Inj. 2 up to Inj. 3 | 14 | Cases | |
| Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | Control Group | Cases: 28 days Post-Inj. 2 up to Inj. 3 | 12 | Cases | |
| Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | CYD Dengue Vaccine Group | Cases:28 days Post-Inj. 2 upto end of Active Phase | 61 | Cases | |
| Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | Control Group | Cases:28 days Post-Inj. 2 upto end of Active Phase | 47 | Cases |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CYD Dengue Vaccine Group | 2,669 | |
| Overall Study | STARTED | Control Group | 1,333 | |
| Overall Study | Received Vaccination 1 | CYD Dengue Vaccine Group | 2,666 | |
| Overall Study | Received Vaccination 1 | Control Group | 1,331 | |
| Overall Study | Received Vaccination 2 | CYD Dengue Vaccine Group | 2,584 | |
| Overall Study | Received Vaccination 2 | Control Group | 1,300 | |
| Overall Study | Received Vaccination 3 | CYD Dengue Vaccine Group | 2,557 | |
| Overall Study | Received Vaccination 3 | Control Group | 1,282 | |
| Overall Study | COMPLETED | CYD Dengue Vaccine Group | 2,552 | |
| Overall Study | COMPLETED | Control Group | 1,276 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events276
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 |
|---|---|---|---|---|---|---|
| other | Headache; Post-Any Injection | Nervous system disorders | CYD Dengue Vaccine Group | 415 | 692 | |
| other | Headache; Post-Any Injection | Nervous system disorders | Control Group | 207 | 349 | |
| other | Injection site Pain; Post-Any | General disorders | CYD Dengue Vaccine Group | 399 | 692 | |
| other | Injection site Pain; Post-Any | General disorders | Control Group | 201 | 349 | |
| other | Injection site Erythema; Post-Any Injection | General disorders | CYD Dengue Vaccine Group | 198 | 692 | |
| other | Injection site Erythema; Post-Any Injection | General disorders | Control Group | 107 | 349 | |
| other | Injection site Swelling; Post-Any Injection | General disorders | CYD Dengue Vaccine Group | 148 | 692 | |
| other | Injection site Swelling; Post-Any Injection | General disorders | Control Group | 77 | 349 | |
| other | Fever; Post-Any Injection | General disorders | CYD Dengue Vaccine Group | 223 | 692 | |
| other | Fever; Post-Any Injection | General disorders | Control Group | 120 | 350 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CYD Dengue Vaccine Group | 1 | 2,666 |
| Total, all-cause mortality | Control Group | 4 | 1,331 |
| Total, other adverse events | CYD Dengue Vaccine Group | 415 | 697 |
| Total, other adverse events | Control Group | 207 | 350 |
| Total, serious adverse events | CYD Dengue Vaccine Group | 315 | 2,666 |
| Total, serious adverse events | Control Group | 176 | 1,331 |
Source ClinicalTrials.gov
Papers6
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/NCT00842530
GET https://conductscience.org/api/trials/v1/NCT00842530/results?page=2