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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1122-1892 | Other Identifier | WHO |
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The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations.
Primary Objectives:
Secondary Objective:
Participants were randomized to 4 different groups to receive either CYD dengue vaccine and/or YF vaccine. Participants who already received YF vaccine prior to enrolment were randomized to one of the 2 groups receiving CYD dengue vaccine alone. Participants were evaluated for immunogenicity, antibody persistence, reactogenicity and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYD Dengue vaccine: Group 1 | Experimental | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. |
|
| CYD Dengue vaccine: Group 2 | Experimental | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
|
| CYD Dengue and Yellow Fever vaccine: Group 3 | Experimental | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
|
| Yellow Fever vaccine: Group 4 | Active Comparator | Participants received single dose of YF vaccine at Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus | Biological | 0.5 mL, Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT). | Pre-injection 1, 28 days and 6 months post-injection 3 |
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). | Pre-injection 1, 28 days and 6 months post-injection 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. | Pre-injection 1 and 2 and 28 days post-injection 1 and 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabaster | Alabama | 35007 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30241510 | Derived | Kirstein J, Douglas W, Thakur M, Boaz M, Papa T, Skipetrova A, Plennevaux E. Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. BMC Infect Dis. 2018 Sep 21;18(1):475. doi: 10.1186/s12879-018-3389-x. |
| 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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A total of 390 participants were enrolled and randomized in the study.
Study participants were enrolled from 06 December 2011 to 22 March 2012 in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | CYD Dengue Vaccine: Group 1 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. |
| FG001 | CYD Dengue Vaccine: Group 2 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus | Biological | 0.5 mL, Subcutaneous |
|
|
| Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus | Biological | 0.5 mL, Subcutaneous |
|
|
| Yellow Fever | Biological | 0.5 mL, Subcutaneous |
|
|
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 |
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). |
| Pre-injection 1 and 2 and 28 days post-injection 1 and 2 |
| Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3 | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution). | Pre-injection 1 and 28 days post-injection 1 |
| Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3 | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution). | Pre-injection 1 and 28 days post-injection 1 |
| Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result). | Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3 |
| Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result). | Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 |
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result). | Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 |
| Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result). | Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3 |
| Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm. | Within 7 days after any injection |
| Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity. | Within 14 days after any injection |
| Sacramento |
| California |
| 95816 |
| United States |
| Jacksonville | Florida | 32216 | United States |
| Silver Spring | Maryland | 20910 | United States |
| Springfield | Missouri | 65802 | United States |
| Las Vegas | Nevada | 89104 | United States |
| West Jordan | Utah | 84088 | United States |
| FG002 | CYD Dengue and Yellow Fever (YF) Vaccine: Group 3 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| FG003 | Yellow Fever Vaccine: Group 4 | Participants received single dose of YF vaccine at Day 0. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Analysis was performed on all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CYD Dengue Vaccine: Group 1 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. |
| BG001 | CYD Dengue Vaccine: Group 2 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| BG002 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| BG003 | Yellow Fever Vaccine: Group 4 | Participants received single dose of YF vaccine at Day 0. |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT). | Full Analysis Set included participants who received at least 1 Inj. of CYD dengue or/ YF vaccine, had at least 1 blood sample drawn and valid post-Inj. serology result. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-injection 1, 28 days and 6 months post-injection 3 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). | Analysis was performed on Full Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4. | Posted | Number | percentage of participants | Pre-injection 1, 28 days and 6 months post-injection 3 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. | Analysis was performed on Full Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3 and 4. | Posted | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | Pre-injection 1 and 2 and 28 days post-injection 1 and 2 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2 | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). | Analysis was performed on Full Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3 and 4. | Posted | Number | Percentage of participants | Pre-injection 1 and 2 and 28 days post-injection 1 and 2 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3 | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution). | Analysis was performed on Full Analysis Set. Here, "Overall number of participants analyzed = participants evaluable for this outcome measure" and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4. | Posted | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | Pre-injection 1 and 28 days post-injection 1 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3 | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution). | Analysis was performed on Full Analysis Set. Here, "Overall number of participants analyzed = participants evaluable for this outcome measure" and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4. | Posted | Number | percentage of participants | Pre-injection 1 and 28 days post-injection 1 |
| |||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result). | Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4. | Posted | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3 |
| ||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) | GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result). | Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4. | Posted | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants) | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result). | Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4. | Posted | Number | percentage of participants | Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3 |
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| Secondary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants) | Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result). | Analysis was performed on Full Analysis Set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4. | Posted | Number | percentage of participants | Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3 |
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| Secondary | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine | Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm. | Analysis was performed on Safety Analysis set which included participants who received at least one injection of CYD dengue vaccine or YF vaccine. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Within 7 days after any injection |
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| Secondary | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity. | Analysis was performed on Safety Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | Within 14 days after any injection |
|
Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Not provided
| 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 1 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. | 0 | 120 | 4 | 120 | 91 | 120 |
| EG001 | CYD Dengue Vaccine: Group 2 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. | 0 | 120 | 4 | 120 | 92 | 120 |
| EG002 | CYD Dengue and Yellow Fever Vaccine: Group 3 | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. | 0 | 119 | 5 | 119 | 92 | 119 |
| EG003 | Yellow Fever Vaccine: Group 4 | Participants received single dose of YF vaccine at Day 0. | 0 | 30 | 0 | 30 | 17 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis Acute | Hepatobiliary disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDra version 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDra version 14.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDra version 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra version 14.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDra version 14.0 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDra version 14.0 | Systematic Assessment |
| |
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDra version 14.0 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra version 14.0 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra version 14.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra version 14.0 | Systematic Assessment |
| |
| Vaginal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra version 14.0 | Systematic Assessment |
| |
| Blighted Ovum | Pregnancy, puerperium and perinatal conditions | MedDra version 14.0 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDra version 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra version 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra version 14.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra version 14.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| D015004 | Yellow Fever |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D022341 | Yellow Fever Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Dengue Virus Serotype 1: 28 days Post-injection 3 |
|
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| Dengue Virus Serotype 1: 6 months Post-injection 3 |
|
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| Dengue Virus Serotype 2: Pre-injection 1 |
|
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| Dengue Virus Serotype 2: 28 days Post-injection 3 |
|
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| Dengue Virus Serotype 2: 6 months Post-injection 3 |
|
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| Dengue Virus Serotype 3: Pre-injection |
|
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| Dengue Virus Serotype 3: 28 days Post-injection 3 |
|
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| Dengue Virus Serotype 3: 6 months Post-injection 3 |
|
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| Dengue Virus Serotype 4: Pre-injection 1 |
|
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| Dengue Virus Serotype 4: Post-injection 3 |
|
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| Dengue Virus Serotype 4: 6 months Post-injection 3 |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
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Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
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| CYD Dengue and Yellow Fever Vaccine: Group 3 |
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
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| CYD Dengue and Yellow Fever Vaccine: Group 3 |
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
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| OG003 | Yellow Fever Vaccine: Group 4 | Participants received single dose of YF vaccine at Day 0. |
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| Yellow Fever Vaccine: Group 4 |
Participants received single dose of YF vaccine at Day 0. |
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