Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-4913 | Other Identifier | WHO | |
| 2014-001714-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration.
Primary Objective:
Secondary Objectives:
All participants received a total of 9 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies was performed in a randomized subset of participants. All participants were followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYD Dengue Vaccine Group | Experimental | Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (Month [M] 0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP-IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
| Placebo Group | Experimental | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live, attenuated dengue serotype 1, 2, 3, and 4 virus | Biological | 0.5 mL, subcutaneous at age 12, 18, and 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dilution [dil]) in flavivirus non-immune participants (defined as those with YF antibodies <10 [1/dil] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus). | 28 days Post-Injection 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cali | Colombia | |||||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
A total of 792 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; 787 participants were vaccinated.
Study participants were enrolled from 07 September 2011 to 08 March 2012 at 2 clinical sites (1 in Colombia and 1 in Peru).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CYD Dengue Vaccine Group | Participants received the Stamaril® and the CYD dengue vaccine (Injection [Inj.] 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
To ensure that objective safety data were obtained, the trial was designed using an observer-blind methodology since the products were visually different and may be recognized. For first trial vaccination (V01), the person who administered the injections knew which products were administered while either the participant or parent nor the Investigator in charge of safety evaluation knew which products were administered.
| Yellow fever vaccine | Biological | 0.5 mL subcutaneous in the deltoid at age 12 to 13 months. |
|
|
| Measles, mumps, and rubella (MMR) vaccine | Biological | 0.5 mL, subcutaneous at age 12 to 13 months. |
|
|
| Pneumococcal Conjugated Vaccine | Biological | 0.5 mL, intramuscular at age 13 to 14 months |
|
| Hepatitis A Pediatric Vaccine | Biological | 0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months |
|
| Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine | Biological | 0.5 mL, intramuscular at age 19 to 20 months |
|
|
| Live, attenuated dengue serotype 1, 2, 3, and 4 virus | Biological | 0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months |
|
|
| Yellow Fever Vaccine | Biological | 0.5 mL, subcutaneous at age 12 to 13 months |
|
|
| Placebo (NaCl) | Biological | 0.5 mL, subcutaneous at age 12 to 13 months |
|
|
| Measles, mumps, and rubella vaccine | Biological | 0.5 mL, subcutaneous at age 13 to 14 months |
|
|
| Pneumococcal Conjugated Vaccine | Biological | 0.5 mL, intramuscular at age 13 to 14 months |
|
| Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine | Biological | 0.5 mL, intramuscular at age 19 to 20 months |
|
|
| Hepatitis A Pediatric Vaccine | Biological | 0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months |
|
| 28 days Post-Injection 1 |
| Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. | Pre-Injection 1 and 28-days Post-Injection 1 |
| Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. | Pre-Injection 1 and 28- days Post-Injection 1 |
| Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dil) regardless of the flavivirus status of participants at baseline. | Pre-Injection 1 and 28-days Post-Injection 1 |
| GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay. | Pre-Injection 1 and 28-days Post-Injections 2 and 3 |
| GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. | Pre-Injection 1 and 28-days Post-Injections 2 and 3 |
| Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers >= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains. | Pre-Injection 1 and 28-days Post-Injections 2 and 3 |
| Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus. | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus. | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus. | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus. | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >39.5°celsius; Vomiting: >= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine. | Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3 |
| Lima |
| Peru |
| FG001 | Placebo Group | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| Vaccinated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on Safety Analysis Set which included all participants who had received at least 1 dose of CYD dengue vaccine, stamaril® vaccine or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CYD Dengue Vaccine Group | Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| BG001 | Placebo Group | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| BG002 | 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 | Months |
| |||||||||||||||||
| 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 | Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dilution [dil]) in flavivirus non-immune participants (defined as those with YF antibodies <10 [1/dil] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus). | Analysis was performed on Per-Protocol analysis set which included all participants who had no protocol deviations. Per-Protocol analysis set was defined for the Stamaril® vaccine immune response. | Posted | Number | Percentage of participants | 28 days Post-Injection 1 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline. | Analysis performed on Full analysis set included participants who received at least co-administration of Stamaril® vaccine with either 1st dose of CYD dengue vaccine or placebo, had blood sample post-Stamaril® vaccination drawn and a valid test result. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | 28 days Post-Injection 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. | Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and 28-days Post-Injection 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. | Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure." | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Pre-Injection 1 and 28- days Post-Injection 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dil) regardless of the flavivirus status of participants at baseline. | Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and 28-days Post-Injection 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay. | Analysis performed on Full analysis set for dengue immunogenicity which included participants who received at least 1dose of CYD dengue vaccine/placebo, had at least 1 blood sample withdrawn and valid post vaccination test results for at least 1 dengue serotype. Here,'number analyzed' =participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and 28-days Post-Injections 2 and 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. | Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titer ratios | Pre-Injection 1 and 28-days Post-Injections 2 and 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers >= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains. | Analysis was performed Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and 28-days Post-Injections 2 and 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. | Analysis was performed Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus. | Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus. | Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dilution) | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus. | Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Number | percentage of participants | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus. | Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Pre-Injection 1 and 28 days Post-Injections 2 and 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >39.5°celsius; Vomiting: >= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine. | Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category. "0" in "number analyzed" field= none of the participants were evaluable since participants did not received CYD dengue vaccine as Injection 1 (Placebo group) or Placebo at any time point (CYD dengue vaccine group). | Posted | Number | Percentage of participants | Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3 |
|
Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (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 in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
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 | Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). | 0 | 394 | 35 | 394 | 211 | 394 |
| EG001 | Placebo Group | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). | 1 | 393 | 38 | 393 | 193 | 393 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA 14.4 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 14.4 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.4 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.4 | Non-systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 14.4 | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 14.4 | Non-systematic Assessment |
| |
| Acute lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.4 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Drowsiness; Post-Any Injection | Nervous system disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Tenderness for Stamaril® vaccine; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Tenderness for CYD dengue vaccine; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Tenderness for placebo; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Erythema for Stamaril® vaccine; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Erythema for CYD dengue vaccine; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Erythema for placebo; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Injection site Swelling for CYD dengue vaccine; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Fever; Post-Any Injection | General disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Crying abnormal; Post-Any injection | Psychiatric disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Irritability; Post-Any injection | Psychiatric disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.4 | Non-systematic Assessment |
| |
| Vomiting; Post-Any injection | Gastrointestinal disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Appetite lost; Post-Any injection | Metabolism and nutrition disorders | MedDRA 14.4 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.4 | Non-systematic Assessment |
|
None reported
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 | |
|---|---|---|---|---|
| Director | Sanofi Pasteur | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| D015004 | Yellow Fever |
| D018177 | Flavivirus Infections |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D022341 | Yellow Fever Vaccine |
| D014612 | Vaccines |
| D022542 | Measles-Mumps-Rubella Vaccine |
| D013745 | Tetanus Toxoid |
| D018073 | Haemophilus Vaccines |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| D014121 | Toxoids |
| D001428 | Bacterial Vaccines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
|
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
|
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
|
| OG001 | Placebo Group | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
|
|