Trial · NCT00842530
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| OTHER_PRE_SPECIFIED | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months) | Analysis was performed on Safety Analysis Set. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Days | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months) | Analysis was performed on Safety Analysis Set. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00842530/outcomes