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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-7380 | Other Identifier | WHO |
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The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530).
The Objectives:
This study was a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530) where participants were initially randomized to receive 3 injections of either CYD dengue vaccine or control at 6 month intervals. Any SAE related to a study procedure or related to a previous injection from study CYD23, or any fatal SAEs (even if unrelated) were reported to the Sponsor.
An Independent Data Monitoring Committee (IDMC) was also involved in the regular review of virologically-confirmed hospitalized dengue cases. Any fatal outcome or related SAE were be promptly reviewed by the IDMC.
No study vaccinations were administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYD Dengue Vaccine Group | Participants who received 3 injections of 0.5 milliliter (mL) CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. | ||
| Control Group | Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) | Cases were defined as the number of participants with at least one hospitalized VCD episode. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) | Episodes were defined as the number of hospitalized VCD episodes. | 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 Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (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. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in study CYD23 (NCT00842530) who were hospitalized with dengue cases.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ratchaburi | Muang District | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33822015 | Derived | Forrat R, Dayan GH, DiazGranados CA, Bonaparte M, Laot T, Capeding MR, Sanchez L, Coronel DL, Reynales H, Chansinghakul D, Hadinegoro SRS, Perroud AP, Frago C, Zambrano B, Machabert T, Wu Y, Luedtke A, Price B, Vigne C, Haney O, Savarino SJ, Bouckenooghe A, Noriega F. Analysis of Hospitalized and Severe Dengue Cases Over the 6 years of Follow-up of the Tetravalent Dengue Vaccine (CYD-TDV) Efficacy Trials in Asia and Latin America. Clin Infect Dis. 2021 Sep 15;73(6):1003-1012. doi: 10.1093/cid/ciab288. | |
| 29897841 |
| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Of the 3997 participants who were treated in the original study CYD23, a total of 3203 participants were included in this CYD57 study to continue the 4-year safety follow-up.
Study participants were enrolled in the original study CYD23 (NCT00842530) from 10 September 2013 to 29 November 2013 at 1 clinic center in Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | CYD Dengue Vaccine Group | Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
| FG001 | Control Group | Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis was performed on Follow-up Analysis Set (FupAS) which included all participants who were included in the study CYD57.
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| ID | Title | Description |
|---|---|---|
| BG000 | CYD Dengue Vaccine Group | Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Analysis was performed on FupAS. | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CYD Dengue Vaccine Group | Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gun-shot wound | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Sanofi Pasteur SA | Contact-US@sanofi.com |
Not provided
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Cases were defined as the number of participants with at least one hospitalized VCD episode. |
| Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) | Episodes were defined as the number of hospitalized VCD episodes. | 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 Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (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. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) | Cases were defined as the number of participants with at least one hospitalized VCD episode. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) | Episodes were defined as the number of hospitalized VCD episodes. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| 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) | Cases were defined as the number of participants with at least one non-serotype specific dengue viremia among hospitalized VCD cases. | 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 |
| Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23) | Quantified viremia was defined as greater than or equal to (>=) lower limit of quantitation (log10 plaque forming unit [pfu]/mL). | Year 1 to Year 4 post-vaccination after 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 sample collection time interval of 14 days |
| Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (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. The WHO criteria were fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Cases were defined as the number of participants with at least one hospitalized VCD episode meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue hemorrhagic fever was graded as - Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation was a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Episodes were defined as the number of hospitalized virologically confirmed dengue episodes meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
| Derived |
| Sridhar S, Luedtke A, Langevin E, Zhu M, Bonaparte M, Machabert T, Savarino S, Zambrano B, Moureau A, Khromava A, Moodie Z, Westling T, Mascarenas C, Frago C, Cortes M, Chansinghakul D, Noriega F, Bouckenooghe A, Chen J, Ng SP, Gilbert PB, Gurunathan S, DiazGranados CA. Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy. N Engl J Med. 2018 Jul 26;379(4):327-340. doi: 10.1056/NEJMoa1800820. Epub 2018 Jun 13. |
| 26214039 | Derived | Hadinegoro SR, Arredondo-Garcia JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, Muhammad Ismail HI, Reynales H, Limkittikul K, Rivera-Medina DM, Tran HN, Bouckenooghe A, Chansinghakul D, Cortes M, Fanouillere K, Forrat R, Frago C, Gailhardou S, Jackson N, Noriega F, Plennevaux E, Wartel TA, Zambrano B, Saville M; CYD-TDV Dengue Vaccine Working Group. Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease. N Engl J Med. 2015 Sep 24;373(13):1195-206. doi: 10.1056/NEJMoa1506223. Epub 2015 Jul 27. |
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Control Group | Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. |
|
|
|
| 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) | Cases were defined as the number of participants with at least one hospitalized VCD episode. | Analysis was performed on FupAS. | Posted | Number | Cases | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | Episodes were defined as the number of hospitalized VCD episodes. | Analysis was performed on FupAS. | Posted | Number | Episodes | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | 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. | Analysis was performed on FupAS. Here, "number analyzed" signifies participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
|
| 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) | Cases were defined as the number of participants with at least one hospitalized VCD episode. | Analysis was performed on FupAS. Here, "number analyzed" signifies participants with evaluable data for each specified category. | Posted | Number | Cases | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | Episodes were defined as the number of hospitalized VCD episodes. | Analysis was performed on FupAS. Here, "number analyzed" signifies participants with evaluable data for each specified category. | Posted | Number | Episodes | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | 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. | Analysis was performed on FupAS. | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | Cases were defined as the number of participants with at least one hospitalized VCD episode. | Analysis was performed on FupAS. | Posted | Number | Cases | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | Episodes were defined as the number of hospitalized VCD episodes. | Analysis was performed on FupAS. | Posted | Number | Episodes | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 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) | Cases were defined as the number of participants with at least one non-serotype specific dengue viremia among hospitalized VCD cases. | Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period. | Posted | Number | Participants | 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 |
|
|
|
| Primary | Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23) | Quantified viremia was defined as greater than or equal to (>=) lower limit of quantitation (log10 plaque forming unit [pfu]/mL). | Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period. | Posted | Mean | Standard Deviation | log10 pfu/mL | Year 1 to Year 4 post-vaccination after 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 sample collection time interval of 14 days |
|
|
|
| Primary | Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (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. The WHO criteria were fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. | Analysis was performed on FupAS. | Posted | Number | 95% Confidence Interval | Events per 100 participant-years | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
|
| Primary | Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Cases were defined as the number of participants with at least one hospitalized VCD episode meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue hemorrhagic fever was graded as - Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation was a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. | Analysis was performed on FupAS. | Posted | Number | Cases | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| Primary | Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23) | Episodes were defined as the number of hospitalized virologically confirmed dengue episodes meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. | Analysis was performed on FupAS. | Posted | Number | Episodes | Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23 |
|
|
|
| 3 |
| 2,131 |
| 3 |
| 2,131 |
| 0 |
| 0 |
| EG001 | Control Group | Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. | 2 | 1,072 | 2 | 1,072 | 0 | 0 |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Drowning | General disorders | MedDRA 10.0 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| Cases: Serotype 2 |
|
| Cases: Serotype 3 |
|
| Cases: Serotype 4 |
|
| Cases: Unserotyped |
|
| Episodes: Serotype 2 |
|
| Episodes: Serotype 3 |
|
| Episodes: Serotype 4 |
|
| Episodes: Unserotyped |
|
| 6 to 11 Years: Any of the 4 Serotypes |
|
|
| 4 to 5 Years: Serotype 1 |
|
|
| 6 to 11 Years: Serotype 1 |
|
|
| 4 to 5 Years: Serotype 2 |
|
|
| 6 to 11 Years: Serotype 2 |
|
|
| 4 to 5 Years: Serotype 3 |
|
|
| 6 to 11 Years: Serotype 3 |
|
|
| 4 to 5 Years: Serotype 4 |
|
|
| 6 to 11 Years: Serotype 4 |
|
|
| 4 to 5 Years: Unserotyped |
|
|
| 6 to 11 Years: Unserotyped |
|
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| Relative Risk; 6 to 11 years; Any Serotype | Relative Risk | 0.807 | 2-Sided | 95 | 0.53 | 1.25 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203. |
| Relative Risk; 4 to 5 years; Serotype 1 | Relative Risk | 4.885 | 2-Sided | 95 | 0.70 | 212.02 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203. |
| Relative Risk; 6 to 11 years; Serotype 1 | Relative Risk | 0.557 | 2-Sided | 95 | 0.21 | 1.46 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203. |
| Relative Risk; 4 to 5 years; Serotype 2 | Relative Risk | 2.931 | 2-Sided | 95 | 0.36 | 134.83 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203. |
| Relative Risk; 6 to 11 years; Serotype 2 | Relative Risk | 1.165 | 2-Sided | 95 | 0.53 | 2.74 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203. |
| Relative Risk; 4 to 5 years; Serotype 3 | Relative Risk | 1.221 | 2-Sided | 95 | 0.20 | 12.83 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203. |
| Relative Risk; 6 to 11 years; Serotype 3 | Relative Risk | 1.013 | 2-Sided | 95 | 0.41 | 2.73 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203. |
| Relative Risk; 4 to 5 years; Serotype 4 | Relative Risk | 0.977 | 2-Sided | 95 | 0.21 | 6.04 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203. |
| Relative Risk; 6 to 11 years; Serotype 4 | Relative Risk | 0.506 | 2-Sided | 95 | 0.18 | 1.44 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203. |
| Relative Risk; 4 to 5 years; Unserotyped | Relative Risk | 0.000 | 2-Sided | 95 | 0.00 | 2.60 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203. |
| Relative Risk; 6 to 11 years; Unserotyped | Relative Risk | 0.000 | 2-Sided | 95 | 0.00 | 19.75 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203. |
| 6 to 11 years cases: Any of the 4 Serotypes |
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| 4 to 5 years cases: Serotype 1 |
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| 6 to 11 years cases: Serotype 1 |
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| 4 to 5 years cases: Serotype 2 |
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| 6 to 11 years cases: Serotype 2 |
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| 4 to 5 years cases: Serotype 3 |
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| 6 to 11 years cases: Serotype 3 |
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| 4 to 5 years cases: Serotype 4 |
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| 6 to 11 years cases: Serotype 4 |
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| 4 to 5 years cases: Unserotyped |
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| 6 to 11 years cases: Unserotyped |
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| 6 to11 years episodes: Any of 4 Serotypes |
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| 4 to 5 years episodes: Serotype 1 |
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| 6 to 11 years episodes: Serotype 1 |
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| 4 to 5 years episodes: Serotype 2 |
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| 6 to 11 years episodes: Serotype 2 |
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| 4 to 5 years episodes: Serotype 3 |
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| 6 to 11 years episodes: Serotype 3 |
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| 4 to 5 years episodes: Serotype 4 |
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| 6 to 11 years episodes: Serotype 4 |
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| 4 to 5 years episodes: Unserotyped |
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| 6 to 11 years episodes: Unserotyped |
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| Serotype 2 |
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| Serotype 3 |
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| Serotype 4 |
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| Unserotyped |
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| Cases: Serotype 2 |
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| Cases: Serotype 3 |
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| Cases: Serotype 4 |
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| Cases: Unserotyped |
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| Episodes: Serotype 2 |
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| Episodes: Serotype 3 |
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| Episodes: Serotype 4 |
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| Episodes: Unserotyped |
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| Cases - 4-7 days |
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| Cases - 0-7 days |
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| Cases - After 7 days |
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| Mean Viremia - 4-7 days |
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| Mean Viremia - 0-7 days |
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| Mean Viremia - After 7 days |
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| Any of the 4 Serotypes: Grade II |
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| Any of the 4 Serotypes: Grade III |
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| Any of the 4 Serotypes: Grade IV |
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| Serotype 1: Any Grade |
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| Serotype 1: Grade I |
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| Serotype 1: Grade II |
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| Serotype 1: Grade III |
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| Serotype 1: Grade IV |
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| Serotype 2: Any Grade |
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| Serotype 2: Grade I |
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| Serotype 2: Grade II |
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| Serotype 2: Grade III |
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| Serotype 2: Grade IV |
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| Serotype 3: Any Grade |
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| Serotype 3: Grade I |
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| Serotype 3: Grade II |
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| Serotype 3 Grade III |
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| Serotype 3: Grade IV |
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| Serotype 4: Any Grade |
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| Serotype 4: Grade I |
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| Serotype 4: Grade II |
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| Serotype 4: Grade III |
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| Serotype 4: Grade IV |
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| Unserotyped: Any Grade |
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| Unserotyped: Grade I |
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| Unserotyped: Grade II |
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| Unserotyped: Grade III |
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| Unserotyped: Grade IV |
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| Relative Risk; Any serotype; Grade I | Relative Risk | 0.252 | 2-Sided | 95 | 0.00 | 4.83 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group. |
| Relative Risk; Any serotype; Grade II | Relative Risk | 2.012 | 2-Sided | 95 | 0.20 | 99.10 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group. |
| Relative Risk; Serotype 2; Any grade | Relative Risk | 0.503 | 2-Sided | 95 | 0.01 | 39.49 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group. |
| Relative Risk; Serotype 2; Grade I | Relative Risk | 0.503 | 2-Sided | 95 | 0.01 | 39.49 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group. |
| Relative Risk; Serotype 4; Any grade | Relative Risk | 0.252 | 2-Sided | 95 | 0.00 | 4.83 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group. |
| Relative Risk; Serotype 4; Grade I | Relative Risk | 0.000 | 2-Sided | 95 | 0.00 | 19.62 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group. |
| Relative Risk; Serotype 4; Grade II | Relative Risk | 0.503 | 2-Sided | 95 | 0.01 | 39.49 | The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day. | Other | Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group. |
| Cases: Any of the 4 Serotypes: Grade II |
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| Cases: Any of the 4 Serotypes: Grade III |
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| Cases: Any of the 4 Serotypes: Grade IV |
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| Cases: Serotype 1: Any Grade |
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| Cases: Serotype 1: Grade I |
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| Cases: Serotype 1: Grade II |
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| Cases: Serotype 1: Grade III |
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| Cases: Serotype 1: Grade IV |
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| Cases: Serotype 2: Any Grade |
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| Cases: Serotype 2: Grade I |
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| Cases: Serotype 2: Grade II |
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| Cases: Serotype 2: Grade III |
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| Cases: Serotype 2: Grade IV |
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| Cases: Serotype 3: Any Grade |
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| Cases: Serotype 3: Grade I |
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| Cases: Serotype 3: Grade II |
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| Cases: Serotype 3: Grade III |
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| Cases: Serotype 3: Grade IV |
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| Cases: Serotype 4: Any Grade |
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| Cases: Serotype 4: Grade I |
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| Cases: Serotype 4: Grade II |
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| Cases: Serotype 4: Grade III |
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| Cases: Serotype 4: Grade IV |
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| Cases: Unserotyped: Any Grade |
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| Cases: Unserotyped: Grade I |
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| Cases: Unserotyped: Grade II |
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| Cases: Unserotyped: Grade III |
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| Cases: Unserotyped: Grade IV |
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| Episodes: Any of the 4 Serotypes: Grade II |
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| Episodes: Any of the 4 Serotypes: Grade III |
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| Episodes: Any of the 4 Serotypes: Grade IV |
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| Episodes: Serotype 1: Any Grade |
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| Episodes: Serotype 1: Grade I |
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| Episodes: Serotype 1: Grade II |
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| Episodes: Serotype 1: Grade III |
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| Episodes: Serotype 1: Grade IV |
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| Episodes: Serotype 2: Any Grade |
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| Episodes: Serotype 2: Grade I |
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| Episodes: Serotype 2: Grade II |
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| Episodes: Serotype 2: Grade III |
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| Episodes: Serotype 2 Grade IV |
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| Episodes: Serotype 3: Any Grade |
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| Episodes: Serotype 3: Grade I |
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| Episodes: Serotype 3: Grade II |
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| Episodes: Serotype 3: Grade III |
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| Episodes: Serotype 3: Grade IV |
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| Episodes: Serotype 4: Any Grade |
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| Episodes: Serotype 4: Grade I |
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| Episodes: Serotype 4: Grade II |
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| Episodes: Serotype 4: Grade III |
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| Episodes: Serotype: 4 Grade IV |
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| Episodes: Unserotyped: Any Grade |
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| Episodes: Unserotyped: Grade I |
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| Episodes: Unserotyped: Grade II |
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| Episodes: Unserotyped: Grade III |
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| Episodes: Unserotyped: Grade IV |
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