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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1115-6290 | Other Identifier | WHO |
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The aim of the study was to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaximâ„¢) during the same day visit but in 2 different sites of administration.
Primary Objective:
Secondary Objectives:
Participants required 8 or 9 clinic visits and received a total of 7 injections. The dengue post-vaccinal viremia was assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity was assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. Participants were followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYD Dengue Vaccine Group 1 | Experimental | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
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| CYD Dengue Vaccine Group 2 | Experimental | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus | Biological | 0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as >=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, >=8 1/dil for poliovirus types 1, 2, and 3, and >=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were < lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels >=4* LLOQ; participants whose pre-vaccination Ab concentrations were >=LLOQ but <4* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels >=4); for participants whose pre-vaccination Ab concentrations were >=4* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination >=2). | 28 days post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaximâ„¢) Administered Concomitantly With CYD Dengue Vaccine | Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT). | Pre-injection 1 and 28 days post-injection 2 and 3 |
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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 |
|---|---|---|---|---|---|---|
| Acapulco de Juárez | Guerrero | CP 39670 | Mexico | |||
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| 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 720 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled, out of which 309 participants were randomized to Group 1 and 315 in Group 2, and 96 participants were not randomized to Group 1 or 2.
Study participants were enrolled from 18 July 2011 to 31 July 2012 at 3 clinical sites in Mexico. The study planned for 732 participants; however, recruitment was stopped when 720 participants were enrolled due to the difficulty in enrolling participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | CYD Dengue Vaccine Group 1 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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An observer-blind design was chosen since the products were visually different. For the second dose of CYD dengue vaccine, the person who administered the injections knew which product was administered while the subject/parent and Investigator were blinded. The first and third doses of CYD dengue vaccine were administered according to an open-label procedure. A placebo dose was administered at Month 7(Group 1) and concomitantly with Pentaxim vaccine at Month 6 (Group 2) to maintain the blind.
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| DTaP IPV//Hib vaccine | Biological | 0.5 mL, intramuscular |
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| Placebo | Biological | 0.5 mL, subcutaneous |
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| Measles, mumps, and rubella vaccine | Biological | 0.5 mL, subcutaneous |
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| Pneumococcal vaccine | Biological | 0.5 mL, intramuscular |
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| Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus | Biological | 0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months |
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| DTaP IPV//Hib vaccine | Biological | 0.5 mL, intramuscular |
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| Placebo | Biological | 0.5 mL, subcutaneously |
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| Measles, mumps, and rubella vaccine | Biological | 0.5 mL, subcutaneous |
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| Pneumococcal vaccine | Biological | 0.5 mL, intramuscular |
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| Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaximâ„¢) Administered Concomitantly With CYD Dengue Vaccine | Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT. | Pre-injection 1 and 28 days post-injection 2 and 3 |
| Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaximâ„¢) Administered Concomitantly With CYD Dengue Vaccine | Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution). | Pre-injection 1 and 28 days post-injection 2 and 3 |
| Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaximâ„¢) Administered With CYD Dengue Vaccine | Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution). | Pre-injection 1 and 28 days post-injection 2 and 3 |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5 degree Celsius (°C); Vomiting: >=6 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. | Day 0 up to Day 14 post-first injection |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 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; and Extensive swelling, severe. | Day 0 up to Day 14 post-booster injection |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 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. | Day 0 up to Day 14 post-second injection |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 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. | Day 0 up to Day 14 post-third injection |
| Guadalajara |
| Jalisco |
| CP 44280 |
| Mexico |
| Monterrey | Nuevo León | CP 64460 | Mexico |
| Mérida | Yucatán | CP 97000 | Mexico |
| FG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
| 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 the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
| BG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine | Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as >=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, >=8 1/dil for poliovirus types 1, 2, and 3, and >=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were < lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels >=4* LLOQ; participants whose pre-vaccination Ab concentrations were >=LLOQ but <4* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels >=4); for participants whose pre-vaccination Ab concentrations were >=4* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination >=2). | Per-protocol analysis set:all participants who had no protocol deviations (not meet inclusion/exclusion criteria,not received vaccine in time window, administration not done per protocol) and could impact Pentaxim vaccine immunogenicity up to Visit 06 (Month 07). Here, 'number analyzed'=participants with available data for each specified category. | Posted | Number | Percentage of participants | 28 days post-injection |
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| Secondary | Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaximâ„¢) Administered Concomitantly With CYD Dengue Vaccine | Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT). | Analysis was performed on Full analysis set for dengue immunogenicity which included participants randomized into the dengue immunogenicity subset who received at least one dose of CYD dengue vaccine. 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 2 and 3 |
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| Secondary | Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaximâ„¢) Administered Concomitantly With CYD Dengue Vaccine | Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT. | 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 ratio | Pre-injection 1 and 28 days post-injection 2 and 3 |
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| Secondary | Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaximâ„¢) Administered Concomitantly With CYD Dengue Vaccine | Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution). | Analysis was performed on 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-injection 2 and 3 |
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| Secondary | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaximâ„¢) Administered With CYD Dengue Vaccine | Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution). | Analysis was performed on 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-injection 2 and 3 |
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| Secondary | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5 degree Celsius (°C); Vomiting: >=6 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. | Analysis was performed on Safety analysis set which included participants who received at least one dose of CYD dengue vaccine, Pentaxim vaccine or placebo. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-first injection |
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| Secondary | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine | 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 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; and Extensive swelling, severe. | Analysis was performed on Safety 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. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-booster injection |
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| Secondary | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine | 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 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. | Analysis was performed on Safety 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. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-second injection |
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| Secondary | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine | 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 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 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. | Analysis was performed on Safety 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. | Posted | Number | Percentage of participants | Day 0 up to Day 14 post-third injection |
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Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months).
Analysis was performed on Safety analysis set.
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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 1 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). | 0 | 309 | 17 | 309 | 145 | 309 |
| EG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). | 1 | 315 | 21 | 315 | 142 | 315 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
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| Acute myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
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| Phimosis | Congenital, familial and genetic disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Encephalitis | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Amoebic dysentery | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Ascariasis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Gastroenteritis bacterial | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness; Post-injection 1 | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Injection site Tenderness; Post-injection 1 | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Injection site Erythema; Post-injection 1 | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Injection site Swelling; Post-injection 1 | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Fever; Post-injection 1 | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Crying abnormal; Post-injection 1 | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
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| Irritability; Post-injection 1 | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Vomiting; Post-injection 1 | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Appetite lost; Post-injection 1 | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (11.0) | Non-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 participant 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 |
| 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 |
|---|---|
| C426945 | Pentavac |
| D022542 | Measles-Mumps-Rubella Vaccine |
| D022242 | Pneumococcal Vaccines |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
Not provided
Not provided
| Male |
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| Anti-tetanus |
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| Anti-polio 1 |
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| Anti-polio 2 |
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| Anti-polio 3 |
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| Anti-PRP |
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| Anti-PT |
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| Anti-FHA |
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| Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | 0.37 | 2-Sided | 95 | -1.14 | 2.07 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
| Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | 0.37 | 2-Sided | 95 | -1.14 | 2.08 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
| Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | 0.0 | 2-Sided | 95 | -1.48 | 1.40 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
| Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | 0.37 | 2-Sided | 95 | -1.15 | 2.09 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
| Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | 0.0 | 2-Sided | 95 | -1.48 | 1.40 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
| Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | -0.56 | 2-Sided | 95 | -3.93 | 2.69 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
| Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection. | Difference in percentage | -0.36 | 2-Sided | 95 | -4.87 | 4.06 | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates. |
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| OG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
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| OG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
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| OG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
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| OG001 | CYD Dengue Vaccine Group 2 | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
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