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Trial record 51 of 1403 for:    Peru

Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01436396
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue
Dengue Hemorrhagic Fever
Yellow Fever
Interventions Biological: Live, attenuated dengue serotype 1, 2, 3, and 4 virus
Biological: Yellow fever vaccine
Biological: Measles, mumps, and rubella (MMR) vaccine
Biological: Pneumococcal Conjugated Vaccine
Biological: Hepatitis A Pediatric Vaccine
Biological: Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine
Biological: Yellow Fever Vaccine
Biological: Placebo (NaCl)
Biological: Measles, mumps, and rubella vaccine
Enrollment 792
Recruitment Details Study participants were enrolled from 07 September 2011 to 08 March 2012 at 2 clinical sites (1 in Colombia and 1 in Peru).
Pre-assignment Details 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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 396 396
Vaccinated 394 393
Completed 364 354
Not Completed 32 42
Reason Not Completed
Protocol Violation             7             5
Adverse Event             1             2
Withdrawal by Subject             19             29
Serious adverse event             2             3
Lost to Follow-up             3             3
Arm/Group Title CYD Dengue Vaccine Group Placebo Group Total
Hide Arm/Group Description 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). 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). Total of all reporting groups
Overall Number of Baseline Participants 394 393 787
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants 393 participants 787 participants
<=18 years
394
 100.0%
393
 100.0%
787
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 394 participants 393 participants 787 participants
12.2  (0.25) 12.2  (0.25) 12.2  (0.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants 393 participants 787 participants
Female
198
  50.3%
203
  51.7%
401
  51.0%
Male
196
  49.7%
190
  48.3%
386
  49.0%
1.Primary Outcome
Title 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
Hide Description 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).
Time Frame 28 days Post-Injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 296 299
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 99.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Placebo Group
Comments Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.334
Confidence Interval (2-Sided) 95%
-0.976 to 1.87
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Hide Description 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.
Time Frame 28 days Post-Injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 378 376
Measure Type: Number
Unit of Measure: Percentage of participants
98.7 99.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Placebo Group
Comments Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-2.81 to 0.383
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Time Frame Pre-Injection 1 and 28-days Post-Injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 381 377
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Pre-Injection 1 Number Analyzed 378 participants 376 participants
5.64
(5.41 to 5.89)
5.67
(5.42 to 5.93)
Post-Injection 1 Number Analyzed 381 participants 377 participants
369
(322 to 423)
423
(375 to 478)
4.Secondary Outcome
Title 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
Hide Description GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Time Frame Pre-Injection 1 and 28- days Post-Injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure."
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 378 376
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
35.1
(30.5 to 40.4)
39.8
(35.3 to 45.0)
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-Injection 1 and 28-days Post-Injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 381 377
Measure Type: Number
Unit of Measure: Percentage of participants
Pre-Injection 1 Number Analyzed 378 participants 376 participants
9.0 9.0
Post-Injection 1 Number Analyzed 381 participants 377 participants
99.5 99.7
6.Secondary Outcome
Title GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Hide Description 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.
Time Frame Pre-Injection 1 and 28-days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 113 113
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Injection 1 Number Analyzed 109 participants 110 participants
5.08
(4.92 to 5.25)
5.00
(5.00 to 5.00)
Serotype 1; Post-Injection 2 Number Analyzed 113 participants 113 participants
47.3
(38.9 to 57.5)
11.8
(9.82 to 14.1)
Serotype 1; Post-Injection 3 Number Analyzed 110 participants 106 participants
89.0
(76.4 to 104)
61.3
(52.5 to 71.5)
Serotype 2; Pre-Injection 1 Number Analyzed 109 participants 107 participants
5.10
(4.96 to 5.23)
5.00
(5.00 to 5.00)
Serotype 2; Post-Injection 2 Number Analyzed 113 participants 113 participants
95.5
(78.0 to 117)
41.1
(33.2 to 51.0)
Serotype 2; Post-Injection 3 Number Analyzed 110 participants 106 participants
173
(142 to 211)
150
(127 to 177)
Serotype 3; Pre-Injection 1 Number Analyzed 106 participants 109 participants
5.05
(4.95 to 5.16)
5.18
(5.00 to 5.37)
Serotype 3; Post-Injection 2 Number Analyzed 113 participants 113 participants
118
(101 to 137)
43.4
(36.0 to 52.3)
Serotype 3; Post-Injection 3 Number Analyzed 110 participants 106 participants
181
(158 to 207)
155
(136 to 176)
Serotype 4; Pre-Injection 1 Number Analyzed 110 participants 112 participants
5.00
(5.00 to 5.00)
5.05
(4.96 to 5.14)
Serotype 4; Post-Injection 2 Number Analyzed 113 participants 113 participants
68.1
(54.6 to 84.9)
29.8
(22.1 to 40.2)
Serotype 4; Post-Injection 3 Number Analyzed 110 participants 106 participants
74.0
(61.3 to 89.4)
74.6
(62.5 to 89.1)
7.Secondary Outcome
Title GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Hide Description GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Time Frame Pre-Injection 1 and 28-days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 113 113
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratios
Serotype 1; Post-Inj.2/Pre-Inj. 1 Number Analyzed 109 participants 110 participants
4.78
(3.91 to 5.84)
1.15
(0.973 to 1.37)
Serotype 1; Post-Inj.3/Pre-Inj. 1 Number Analyzed 107 participants 104 participants
8.82
(7.55 to 10.3)
6.14
(5.26 to 7.18)
Serotype 2; Post-Inj.2/Pre-Inj. 1 Number Analyzed 109 participants 107 participants
9.55
(7.75 to 11.8)
3.86
(3.15 to 4.72)
Serotype 2; Post-Inj.3/Pre-Inj. 1 Number Analyzed 107 participants 102 participants
16.7
(13.7 to 20.4)
15.2
(12.8 to 18.1)
Serotype 3; Post-Inj.2/Pre-Inj. 1 Number Analyzed 106 participants 109 participants
11.6
(9.98 to 13.5)
4.16
(3.46 to 5.00)
Serotype 3; Post-Inj.3/Pre-Inj. 1 Number Analyzed 104 participants 104 participants
18.0
(15.6 to 20.8)
15.4
(13.5 to 17.6)
Serotype 4; Post-Inj.2/Pre-Inj. 1 Number Analyzed 110 participants 112 participants
6.82
(5.44 to 8.55)
2.89
(2.15 to 3.89)
Serotype 4; Post-Inj.3/Pre-Inj. 1 Number Analyzed 108 participants 106 participants
7.26
(6.02 to 8.77)
7.44
(6.24 to 8.88)
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-Injection 1 and 28-days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 113 113
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 Number Analyzed 109 participants 110 participants
0.9 0.0
Serotype 1; Post-Injection 2 Number Analyzed 113 participants 113 participants
92.0 51.3
Serotype 1; Post-Injection 3 Number Analyzed 110 participants 106 participants
100.0 97.2
Serotype 2; Pre-Injection 1 Number Analyzed 109 participants 107 participants
1.8 0.0
Serotype 2; Post-Injection 2 Number Analyzed 113 participants 113 participants
97.3 86.7
Serotype 2; Post-Injection 3 Number Analyzed 110 participants 106 participants
100.0 100.0
Serotype 3; Pre-Injection 1 Number Analyzed 106 participants 109 participants
0.9 3.7
Serotype 3; Post-Injection 2 Number Analyzed 113 participants 113 participants
100.0 90.3
Serotype 3; Post-Injection 3 Number Analyzed 110 participants 106 participants
100.0 100.0
Serotype 4; Pre-Injection 1 Number Analyzed 110 participants 112 participants
0.0 0.9
Serotype 4; Post-Injection 2 Number Analyzed 113 participants 113 participants
91.2 68.1
Serotype 4; Post-Injection 3 Number Analyzed 110 participants 106 participants
97.3 98.1
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-Injection 1 and 28 days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 113 113
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-Injection 1 Number Analyzed 111 participants 112 participants
3.6 4.5
At least 1 serotype; Post-Injection 2 Number Analyzed 113 participants 113 participants
100.0 93.8
At least 1 serotype; Post-Injection 3 Number Analyzed 110 participants 106 participants
100.0 100.0
At least 2 serotypes; Pre-Injection 1 Number Analyzed 111 participants 112 participants
0.0 0.0
At least 2 serotypes; Post-Injection 2 Number Analyzed 113 participants 113 participants
100.0 87.6
At least 2 serotypes; Post-Injection 3 Number Analyzed 110 participants 106 participants
100.0 100.0
At least 3 serotypes; Pre-Injection 1 Number Analyzed 111 participants 112 participants
0.0 0.0
At least 3 serotypes; Post-Injection 2 Number Analyzed 113 participants 113 participants
94.7 73.5
At least 3 serotypes; Post-Injection 3 Number Analyzed 110 participants 106 participants
100.0 98.1
All 4 serotypes; Pre-Injection 1 Number Analyzed 111 participants 112 participants
0.0 0.0
All 4 serotypes; Post-Injection 2 Number Analyzed 113 participants 113 participants
85.8 41.6
All 4 serotypes; Post-Injection 3 Number Analyzed 110 participants 106 participants
97.3 97.2
10.Secondary Outcome
Title GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Hide Description 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.
Time Frame Pre-Injection 1 and 28 days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 10 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Injection 1 Number Analyzed 10 participants 13 participants
5.96
(4.01 to 8.87)
5.00
(5.00 to 5.00)
Serotype 1; Post-Injection 2 Number Analyzed 10 participants 14 participants
52.5
(25.0 to 110)
17.0
(7.63 to 38.0)
Serotype 1; Post-Injection 3 Number Analyzed 9 participants 13 participants
81.7
(47.3 to 141)
59.5
(44.6 to 79.5)
Serotype 2; Pre-Injection 1 Number Analyzed 10 participants 12 participants
6.14
(4.50 to 8.38)
5.00
(5.00 to 5.00)
Serotype 2; Post-Injection 2 Number Analyzed 10 participants 14 participants
72.4
(47.4 to 111)
74.3
(27.6 to 200)
Serotype 2; Post-Injection 3 Number Analyzed 9 participants 13 participants
110
(75.5 to 160)
133
(95.7 to 186)
Serotype 3; Pre-Injection 1 Number Analyzed 8 participants 13 participants
5.74
(4.15 to 7.94)
6.75
(5.05 to 9.03)
Serotype 3; Post-Injection 2 Number Analyzed 10 participants 14 participants
102
(54.8 to 189)
95.8
(61.3 to 150)
Serotype 3; Post-Injection 3 Number Analyzed 9 participants 13 participants
143
(89.7 to 227)
126
(91.7 to 173)
Serotype 4; Pre-Injection 1 Number Analyzed 10 participants 13 participants
5.00
(5.00 to 5.00)
5.41
(4.55 to 6.43)
Serotype 4; Post-Injection 2 Number Analyzed 10 participants 14 participants
87.1
(36 to 210)
109
(44.7 to 265)
Serotype 4; Post-Injection 3 Number Analyzed 9 participants 13 participants
77.1
(24.0 to 248)
74.3
(40.9 to 135)
11.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-Injection 1 and 28 days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 94 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Injection 1 Number Analyzed 94 participants 90 participants
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 1; Post-Injection 2 Number Analyzed 94 participants 90 participants
45.9
(37.0 to 57.0)
11.4
(9.42 to 13.7)
Serotype 1; Post-Injection 3 Number Analyzed 93 participants 86 participants
86.6
(73.0 to 103)
61.8
(51.5 to 74.3)
Serotype 2; Pre-Injection 1 Number Analyzed 94 participants 90 participants
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 2; Post-Injection 2 Number Analyzed 94 participants 90 participants
99.0
(78.0 to 126)
39.0
(31.4 to 48.5)
Serotype 2; Post-Injection 3 Number Analyzed 93 participants 86 participants
174
(139 to 218)
157
(129 to 192)
Serotype 3; Pre-Injection 1 Number Analyzed 94 participants 90 participants
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 3; Post-Injection 2 Number Analyzed 94 participants 90 participants
118
(101 to 139)
37.9
(30.8 to 46.8)
Serotype 3; Post-Injection 3 Number Analyzed 93 participants 86 participants
184
(158 to 214)
160
(138 to 187)
Serotype 4; Pre-Injection 1 Number Analyzed 94 participants 90 participants
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 4; Post-Injection 2 Number Analyzed 94 participants 90 participants
66.4
(51.8 to 85.1)
24.0
(17.4 to 33.2)
Serotype 4; Post-Injection 3 Number Analyzed 93 participants 86 participants
73.0
(60.0 to 88.7)
72.2
(59.1 to 88.1)
12.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-Injection 1 and 28 days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 10 14
Measure Type: Number
Unit of Measure: percentage of participants
Serotype 1; Pre-Injection 1 Number Analyzed 10 participants 13 participants
10.0 0.0
Serotype 1; Post-Injection 2 Number Analyzed 10 participants 14 participants
90.0 57.1
Serotype 1; Post-Injection 3 Number Analyzed 9 participants 13 participants
100.0 100.0
Serotype 2; Pre-Injection 1 Number Analyzed 10 participants 12 participants
20.0 0.0
Serotype 2; Post-Injection 2 Number Analyzed 10 participants 14 participants
100.0 92.9
Serotype 2; Post-Injection 3 Number Analyzed 9 participants 13 participants
100.0 100.0
Serotype 3; Pre-Injection 1 Number Analyzed 8 participants 13 participants
12.5 30.8
Serotype 3; Post-Injection 2 Number Analyzed 10 participants 14 participants
100.0 100.0
Serotype 3; Post-Injection 3 Number Analyzed 9 participants 13 participants
100.0 100.0
Serotype 4; Pre-Injection 1 Number Analyzed 10 participants 13 participants
0.0 7.7
Serotype 4; Post-Injection 2 Number Analyzed 10 participants 14 participants
90.0 92.9
Serotype 4; Post-Injection 3 Number Analyzed 9 participants 13 participants
88.9 100.0
13.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-Injection 1 and 28 days Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 Number Analyzed 94 participants 90 participants
0.0 0.0
Serotype 1; Post-Injection 2 Number Analyzed 94 participants 90 participants
92.6 51.1
Serotype 1; Post-Injection 3 Number Analyzed 93 participants 86 participants
100.0 96.5
Serotype 2; Pre-Injection 1 Number Analyzed 94 participants 90 participants
0.0 0.0
Serotype 2; Post-Injection 2 Number Analyzed 94 participants 90 participants
96.8 86.7
Serotype 2; Post-Injection 3 Number Analyzed 93 participants 86 participants
100.0 100.0
Serotype 3; Pre-Injection 1 Number Analyzed 94 participants 90 participants
0.0 0.0
Serotype 3; Post-Injection 2 Number Analyzed 94 participants 90 participants
100.0 87.8
Serotype 3; Post-Injection 3 Number Analyzed 93 participants 86 participants
100.0 100.0
Serotype 4; Pre-Injection 1 Number Analyzed 94 participants 90 participants
0.0 0.0
Serotype 4; Post-Injection 2 Number Analyzed 94 participants 90 participants
90.4 63.3
Serotype 4; Post-Injection 3 Number Analyzed 93 participants 86 participants
97.8 97.7
14.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 394 393
Measure Type: Number
Unit of Measure: Percentage of participants
Inj. site Tenderness for Stamaril®; Post-Any Inj. Number Analyzed 386 participants 386 participants
25.4 17.6
Grd 3 Inj. site Tenderness, Stamaril®;Post-Any Inj Number Analyzed 386 participants 386 participants
0.3 0.3
Inj. site Tenderness for CYD dengue;Post-Any Inj. Number Analyzed 386 participants 363 participants
36.5 28.9
Grd 3 Inj site Tenderness, CYDdengue;Post-Any Inj Number Analyzed 386 participants 363 participants
0.3 0.0
Inj. site Tenderness for placebo; Post-Any Inj. Number Analyzed 0 participants 386 participants
19.7
Grd 3 Inj. site Tenderness, placebo;Post-Any Inj. Number Analyzed 0 participants 386 participants
0.3
Inj. site Erythema for Stamaril®; Post-Any Inj. Number Analyzed 386 participants 386 participants
8.3 9.8
Grd 3 Inj. site Erythema, Stamaril®;Post-Any Inj. Number Analyzed 386 participants 386 participants
0.0 0.0
Inj. site Erythema for CYD dengue;Post-Any Inj. Number Analyzed 386 participants 363 participants
12.7 8.8
Grd 3 Inj. site Erythema, CYD dengue;Post-Any Inj Number Analyzed 386 participants 363 participants
0.0 0.0
Inj. site Erythema for placebo; Post-Any Inj. Number Analyzed 0 participants 386 participants
10.9
Grd 3 Inj. site Erythema for placebo; Post-Any Inj Number Analyzed 0 participants 386 participants
0
Inj. site Swelling for Stamaril®; Post-Any Inj. Number Analyzed 386 participants 386 participants
4.7 4.4
Grd 3 Inj. site Swelling, Stamaril®; Post-Any Inj. Number Analyzed 386 participants 386 participants
0.0 0.0
Inj. site Swelling for CYD dengue; Post-Any Inj. Number Analyzed 386 participants 363 participants
7.5 6.1
Grd 3 Inj. site Swelling, CYD dengue; Post-Any Inj Number Analyzed 386 participants 363 participants
0.0 0.0
Inj. site Swelling for placebo; Post-Any inj. Number Analyzed 0 participants 386 participants
4.9
Grd 3 Inj. site Swelling for placebo; Post-Any Inj Number Analyzed 0 participants 386 participants
0
Inj. site Tenderness for Stamaril®; Post-Inj. 1 Number Analyzed 386 participants 386 participants
25.4 17.6
Grd 3 Inj. site Tenderness, Stamaril®; Post-Inj. 1 Number Analyzed 386 participants 386 participants
0.3 0.3
Inj. site Tenderness for CYD dengue; Post-Inj. 1 Number Analyzed 386 participants 0 participants
24.9
Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 1 Number Analyzed 386 participants 0 participants
0.0
Inj. site Tenderness for placebo; Post-Inj. 1 Number Analyzed 0 participants 386 participants
19.7
Grd 3 Inj. site Tenderness, placebo; Post-Inj. 1 Number Analyzed 0 participants 386 participants
0.3
Inj. site Erythema for Stamaril®; Post-Inj. 1 Number Analyzed 386 participants 386 participants
8.3 9.8
Grd 3 Inj.site Erythema for Stamaril®; Post-Inj. 1 Number Analyzed 386 participants 386 participants
0.0 0.0
Inj. site Erythema for CYD dengue; Post-Inj. 1 Number Analyzed 386 participants 0 participants
8.8
Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 1 Number Analyzed 386 participants 0 participants
0.0
Inj. site Erythema for placebo; Post-Inj. 1 Number Analyzed 0 participants 386 participants
10.9
Grd 3 Inj. site Erythema for placebo; Post-Inj. 1 Number Analyzed 0 participants 386 participants
0
Inj. site Swelling for Stamaril®; Post-Inj. 1 Number Analyzed 386 participants 386 participants
4.7 4.4
Grd 3 Inj.site Swelling for Stamaril®; Post-Inj. 1 Number Analyzed 386 participants 386 participants
0.0 0.0
Inj. site Swelling for CYD dengue; Post-Inj. 1 Number Analyzed 386 participants 0 participants
4.7
Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 1 Number Analyzed 386 participants 0 participants
0.0
Inj. site Swelling for placebo; Post-Inj. 1 Number Analyzed 0 participants 386 participants
4.9
Grd 3 Inj. site Swelling for placebo; Post-Inj. 1 Number Analyzed 0 participants 386 participants
0
Inj. site Tenderness for CYD dengue; Post-Inj. 2 Number Analyzed 371 participants 363 participants
17.0 20.4
Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 2 Number Analyzed 371 participants 363 participants
0.0 0.0
Inj. site Erythema for CYD dengue; Post-Inj. 2 Number Analyzed 371 participants 363 participants
5.1 8.0
Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 2 Number Analyzed 371 participants 363 participants
0.0 0.0
Inj. site Swelling for CYD dengue; Post-Inj. 2 Number Analyzed 371 participants 363 participants
2.7 4.7
Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 2 Number Analyzed 371 participants 363 participants
0.0 0.0
Inj. site Tenderness for CYD dengue; Post-Inj. 3 Number Analyzed 364 participants 355 participants
14.6 16.3
Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 3 Number Analyzed 364 participants 355 participants
0.3 0.0
Inj. site Erythema for CYD dengue; Post-Inj. 3 Number Analyzed 364 participants 355 participants
3.6 4.2
Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 3 Number Analyzed 364 participants 355 participants
0.0 0.0
Inj. site Swelling for CYD dengue; Post-Inj. 3 Number Analyzed 364 participants 355 participants
1.6 2.8
Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 3 Number Analyzed 364 participants 355 participants
0.0 0.0
Fever; Post-Any Injection Number Analyzed 385 participants 385 participants
48.1 40.3
Grade 3 Fever; Post-Any Injection Number Analyzed 385 participants 385 participants
1.3 0.8
Vomiting; Post-Any Injection Number Analyzed 386 participants 386 participants
30.6 27.2
Grade 3 Vomiting; Post-Any Injection Number Analyzed 386 participants 386 participants
1.3 2.1
Crying abnormal; Post-Any Injection Number Analyzed 386 participants 386 participants
47.2 44.0
Grade 3 Crying abnormal; Post-Any Injection Number Analyzed 386 participants 386 participants
0.5 1.3
Drowsiness; Post-Any Injection Number Analyzed 386 participants 386 participants
36.3 33.9
Grade 3 Drowsiness; Post-Any Injection Number Analyzed 386 participants 386 participants
0.5 0.0
Appetite lost; Post-Any Injection Number Analyzed 386 participants 386 participants
54.7 50.0
Grade 3 Appetite lost; Post-Any Injection Number Analyzed 386 participants 386 participants
4.7 3.6
Irritability; Post-Any Injection Number Analyzed 386 participants 386 participants
46.4 46.4
Grade 3 Irritability; Post-Any Injection Number Analyzed 386 participants 386 participants
1.6 1.6
Fever; Post-Injection 1 Number Analyzed 378 participants 375 participants
26.7 16.5
Grade 3 Fever; Post-Injection 1 Number Analyzed 378 participants 375 participants
1.1 0.3
Vomiting; Post-Injection 1 Number Analyzed 386 participants 386 participants
16.1 17.1
Grade 3 Vomiting; Post-Injection 1 Number Analyzed 386 participants 386 participants
0.5 1.0
Crying abnormal; Post-Injection 1 Number Analyzed 386 participants 386 participants
32.9 32.1
Grade 3 Crying abnormal; Post-Injection 1 Number Analyzed 386 participants 386 participants
0.5 1.3
Drowsiness; Post-Injection 1 Number Analyzed 386 participants 386 participants
24.4 22.0
Grade 3 Drowsiness; Post-Injection 1 Number Analyzed 386 participants 386 participants
0.5 0.0
Appetite lost; Post-Injection 1 Number Analyzed 386 participants 386 participants
39.6 33.7
Grade 3 Appetite lost; Post-Injection 1 Number Analyzed 386 participants 386 participants
4.4 3.1
Irritability; Post-Injection 1 Number Analyzed 386 participants 386 participants
38.6 34.7
Grade 3 Irritability; Post-Injection 1 Number Analyzed 386 participants 386 participants
1.6 1.3
Fever; Post-Injection 2 Number Analyzed 363 participants 352 participants
21.2 22.2
Grade 3 Fever; Post-Injection 2 Number Analyzed 363 participants 352 participants
0.0 0.3
Vomiting; Post-Injection 2 Number Analyzed 371 participants 363 participants
12.4 8.8
Grade 3 Vomiting; Post-Injection 2 Number Analyzed 371 participants 363 participants
0.5 0.6
Crying abnormal; Post-Injection 2 Number Analyzed 371 participants 363 participants
19.7 21.8
Grade 3 Crying abnormal; Post-Injection 2 Number Analyzed 371 participants 363 participants
0.0 0.0
Drowsiness; Post-Injection 2 Number Analyzed 371 participants 363 participants
12.7 16.5
Grade 3 Drowsiness; Post-Injection 2 Number Analyzed 371 participants 363 participants
0.0 0.0
Appetite lost; Post-Injection 2 Number Analyzed 371 participants 363 participants
27.0 23.1
Grade 3 Appetite lost; Post-Injection 2 Number Analyzed 371 participants 363 participants
0.3 0.3
Irritability; Post-Injection 2 Number Analyzed 371 participants 363 participants
17.3 22.3
Grade 3 Irritability; Post-Injection 2 Number Analyzed 371 participants 363 participants
0.0 0.0
Fever; Post-Injection 3 Number Analyzed 344 participants 332 participants
20.3 17.8
Grade 3 Fever; Post-Injection 3 Number Analyzed 344 participants 332 participants
0.3 0.3
Vomiting; Post-Injection 3 Number Analyzed 364 participants 355 participants
7.4 7.3
Grade 3 Vomiting; Post-Injection 3 Number Analyzed 364 participants 355 participants
0.3 0.6
Crying abnormal; Post-Injection 3 Number Analyzed 364 participants 355 participants
15.1 14.6
Grade 3 Crying abnormal; Post-Injection 3 Number Analyzed 364 participants 355 participants
0.0 0.0
Drowsiness; Post-Injection 3 Number Analyzed 364 participants 355 participants
11.3 10.7
Grade 3 Drowsiness; Post-Injection 3 Number Analyzed 364 participants 355 participants
0.0 0.0
Appetite lost; Post-Injection 3 Number Analyzed 364 participants 355 participants
19.8 18.6
Grade 3 Appetite lost; Post-Injection 3 Number Analyzed 364 participants 355 participants
0.0 0.3
Irritability; Post-Injection 3 Number Analyzed 364 participants 355 participants
14.3 16.1
Grade 3 Irritability; Post-Injection 3 Number Analyzed 364 participants 355 participants
0.0 0.3
Time Frame Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
Adverse Event Reporting Description 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.
 
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description 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). 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).
All-Cause Mortality
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/394 (0.00%)      1/393 (0.25%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/394 (8.88%)      38/393 (9.67%)    
Blood and lymphatic system disorders     
Lymphadenitis * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Lymphadenopathy * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Gastrointestinal disorders     
Enteritis * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Infections and infestations     
Abscess * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Acute sinusitis * 1  2/394 (0.51%)  2 1/393 (0.25%)  1
Cellulitis * 1  2/394 (0.51%)  2 1/393 (0.25%)  1
Cellulitis orbital * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Dengue fever * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Diarrhoea infectious * 1  1/394 (0.25%)  1 1/393 (0.25%)  1
Gastroenteritis * 1  0/394 (0.00%)  0 2/393 (0.51%)  2
Gastroenteritis viral * 1  1/394 (0.25%)  1 1/393 (0.25%)  1
Impetigo * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Meningitis viral * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Oral herpes * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Pharyngitis * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Pneumonia * 1  12/394 (3.05%)  16 11/393 (2.80%)  11
Pneumonia viral * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Sinusitis * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Tracheitis * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Urinary tract infection * 1  4/394 (1.02%)  4 3/393 (0.76%)  3
Viral infection * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Injury, poisoning and procedural complications     
Accidental exposure * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Burns second degree * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Humerus fracture * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Thermal burn * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Tongue injury * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Traumatic brain injury * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Metabolism and nutrition disorders     
Malnutrition * 1  1/394 (0.25%)  1 0/393 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukemia * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Nervous system disorders     
Convulsion * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Encephalitis * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Febrile convulsion * 1  6/394 (1.52%)  7 4/393 (1.02%)  4
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
Asthmatic crisis * 1  0/394 (0.00%)  0 1/393 (0.25%)  1
1
Term from vocabulary, MedDRA 14.4
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   211/394 (53.55%)      193/393 (49.11%)    
Gastrointestinal disorders     
Diarrhoea * 1  61/394 (15.48%)  73 59/393 (15.01%)  71
Vomiting; Post-Any injection  1  118/386 (30.57%)  135 105/386 (27.20%)  124
General disorders     
Injection site Tenderness for Stamaril® vaccine; Post-Any Injection  1  98/386 (25.39%)  98 68/386 (17.62%)  68
Injection site Tenderness for CYD dengue vaccine; Post-Any Injection  1  141/386 (36.53%)  212 105/363 (28.93%)  132
Injection site Tenderness for placebo; Post-Any Injection  1  0/394 (0.00%)  0 76/386 (19.69%)  76
Injection site Erythema for Stamaril® vaccine; Post-Any Injection  1  32/386 (8.29%)  32 38/386 (9.84%)  38
Injection site Erythema for CYD dengue vaccine; Post-Any Injection  1  49/386 (12.69%)  66 32/363 (8.82%)  44
Injection site Erythema for placebo; Post-Any Injection  1  0/394 (0.00%)  0 42/393 (10.69%)  42
Injection site Swelling for CYD dengue vaccine; Post-Any Injection  1  29/386 (7.51%)  34 22/363 (6.06%)  27
Fever; Post-Any Injection  1  185/385 (48.05%)  248 155/385 (40.26%)  199
Infections and infestations     
Gastroenteritis * 1  44/394 (11.17%)  46 43/393 (10.94%)  49
Nasopharyngitis * 1  118/394 (29.95%)  140 120/393 (30.53%)  140
Pharyngitis * 1  73/394 (18.53%)  90 52/393 (13.23%)  65
Metabolism and nutrition disorders     
Appetite lost; Post-Any injection  1  211/394 (53.55%)  325 193/393 (49.11%)  280
Nervous system disorders     
Drowsiness; Post-Any Injection  1  140/386 (36.27%)  182 131/386 (33.94%)  183
Psychiatric disorders     
Crying abnormal; Post-Any injection  1  182/394 (46.19%)  255 170/393 (43.26%)  255
Irritability; Post-Any injection  1  179/394 (45.43%)  265 179/393 (45.55%)  272
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  26/394 (6.60%)  29 18/393 (4.58%)  21
Cough * 1  24/394 (6.09%)  27 22/393 (5.60%)  24
1
Term from vocabulary, MedDRA 14.4
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director
Organization: Sanofi Pasteur
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01436396     History of Changes
Other Study ID Numbers: CYD29
U1111-1116-4913 ( Other Identifier: WHO )
2014-001714-26 ( EudraCT Number )
First Submitted: September 7, 2011
First Posted: September 19, 2011
Results First Submitted: April 16, 2019
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019