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Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT01411241
Recruitment Status : Completed
First Posted : August 8, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue
Dengue Hemorrhagic Fever
Interventions Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
Biological: DTaP IPV//Hib vaccine
Biological: Placebo
Biological: Measles, mumps, and rubella vaccine
Biological: Pneumococcal vaccine
Enrollment 720
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 309 315
Completed 298 293
Not Completed 11 22
Reason Not Completed
Protocol Violation             0             5
Withdrawal by Subject             9             10
Serious Adverse Event             0             3
Lost to Follow-up             2             4
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2 Total
Hide Arm/Group Description 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). 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). Total of all reporting groups
Overall Number of Baseline Participants 309 315 624
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
1 month to 23 months Number Analyzed 309 participants 315 participants 624 participants
309 315 624
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 309 participants 315 participants 624 participants
Female
146
  47.2%
139
  44.1%
285
  45.7%
Male
163
  52.8%
176
  55.9%
339
  54.3%
1.Primary Outcome
Title 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
Hide Description 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).
Time Frame 28 days post-injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 256 270
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-diphtheria Number Analyzed 255 participants 270 participants
100.0 100.0
Anti-tetanus Number Analyzed 255 participants 270 participants
100.0 99.6
Anti-polio 1 Number Analyzed 256 participants 269 participants
100.0 99.6
Anti-polio 2 Number Analyzed 256 participants 270 participants
100.0 100.0
Anti-polio 3 Number Analyzed 254 participants 267 participants
100 99.6
Anti-PRP Number Analyzed 256 participants 270 participants
100.0 100.0
Anti-PT Number Analyzed 255 participants 269 participants
96.5 97.0
Anti-FHA Number Analyzed 256 participants 270 participants
93.0 93.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.48 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-1.14 to 2.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-1.14 to 2.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.48 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-1.15 to 2.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.48 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-3.93 to 2.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group 1, CYD Dengue Vaccine Group 2
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-4.87 to 4.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Hide Description Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT).
Time Frame Pre-injection 1 and 28 days post-injection 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 109 107
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-injection 1 Number Analyzed 109 participants 107 participants
5.28
(4.82 to 5.78)
5.35
(4.85 to 5.91)
Serotype 1; Post-injection 2 Number Analyzed 105 participants 103 participants
39.8
(30.5 to 51.9)
62.8
(48.1 to 82.0)
Serotype 1; Post-injection 3 Number Analyzed 102 participants 98 participants
93.1
(76.6 to 113)
97.0
(78.8 to 120)
Serotype 2; Pre-injection 1 Number Analyzed 109 participants 107 participants
5.22
(4.89 to 5.57)
5.53
(5.04 to 6.07)
Serotype 2; Post-injection 2 Number Analyzed 105 participants 103 participants
109
(80.2 to 149)
121
(89.3 to 164)
Serotype 2; Post-injection 3 Number Analyzed 102 participants 98 participants
189
(156 to 228)
208
(166 to 261)
Serotype 3; Pre-injection 1 Number Analyzed 109 participants 107 participants
5.26
(4.93 to 5.62)
5.38
(4.95 to 5.84)
Serotype 3; Post-injection 2 Number Analyzed 105 participants 103 participants
92.8
(75.7 to 114)
116
(91.1 to 149)
Serotype 3; Post-injection 3 Number Analyzed 102 participants 98 participants
196
(168 to 229)
217
(183 to 256)
Serotype 4; Pre-injection 1 Number Analyzed 109 participants 106 participants
5.11
(4.94 to 5.28)
5.00
(5.00 to 5.00)
Serotype 4; Post-injection 2 Number Analyzed 105 participants 103 participants
57.8
(44.5 to 75.2)
104
(81.7 to 131)
Serotype 4; Post-injection 3 Number Analyzed 102 participants 98 participants
121
(103 to 142)
127
(103 to 155)
3.Secondary Outcome
Title Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Hide Description Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT.
Time Frame Pre-injection 1 and 28 days post-injection 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 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 109 107
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
Serotype 1: Post-inj 2 value/pre-inj 1 value Number Analyzed 105 participants 103 participants
3.81
(2.95 to 4.93)
5.97
(4.64 to 7.68)
Serotype 1: Post-inj 3 value/pre-inj 1 value Number Analyzed 102 participants 98 participants
8.91
(7.40 to 10.7)
9.20
(7.55 to 11.2)
Serotype 2: Post-inj 2 value/pre-inj 1 value Number Analyzed 105 participants 103 participants
10.6
(7.77 to 14.5)
11.5
(8.50 to 15.4)
Serotype 2: Post-inj 3 value/pre-inj 1 value Number Analyzed 102 participants 98 participants
18.3
(15.1 to 22.1)
19.6
(15.6 to 24.7)
Serotype 3: Post-inj 2 value/pre-inj 1 value Number Analyzed 105 participants 103 participants
8.97
(7.33 to 11.0)
11.1
(8.73 to 14.1)
Serotype 3: Post-inj 3 value/pre-inj 1 value Number Analyzed 102 participants 98 participants
19.1
(16.4 to 22.2)
20.6
(17.4 to 24.4)
Serotype 4: Post-inj 2 value/pre-inj 1 value Number Analyzed 105 participants 102 participants
5.73
(4.40 to 7.45)
10.0
(7.96 to 12.6)
Serotype 4: Post-inj 3 value/pre-inj 1 value Number Analyzed 102 participants 97 participants
12.0
(10.2 to 14.1)
12.6
(10.3 to 15.5)
4.Secondary Outcome
Title 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 (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine
Hide Description Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution).
Time Frame Pre-injection 1 and 28 days post-injection 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 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-injection 1 Number Analyzed 109 participants 107 participants
1.8 2.8
Serotype 1; Post-injection 2 Number Analyzed 105 participants 103 participants
84.8 92.2
Serotype 1; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
Serotype 2; Pre-injection 1 Number Analyzed 109 participants 107 participants
1.8 4.7
Serotype 2; Post-injection 2 Number Analyzed 105 participants 103 participants
98.1 96.1
Serotype 2; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
Serotype 3; Pre-injection 1 Number Analyzed 109 participants 107 participants
2.8 3.7
Serotype 3; Post-injection 2 Number Analyzed 105 participants 103 participants
100.0 98.1
Serotype 3; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
Serotype 4; Pre-injection 1 Number Analyzed 109 participants 106 participants
1.8 0.0
Serotype 4; Post-injection 2 Number Analyzed 105 participants 103 participants
90.5 96.1
Serotype 4; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
5.Secondary Outcome
Title 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 (Pentaxim™) Administered With CYD Dengue Vaccine
Hide Description Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution).
Time Frame Pre-injection 1 and 28 days post-injection 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 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 109 107
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-injection 1 Number Analyzed 109 participants 107 participants
4.6 8.4
At least 1 serotype; Post-injection 2 Number Analyzed 105 participants 103 participants
100.0 100.0
At least 1 serotype; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
At least 2 serotypes; Pre-injection 1 Number Analyzed 109 participants 107 participants
1.8 1.9
At least 2 serotypes; Post-injection 2 Number Analyzed 105 participants 103 participants
100.0 98.1
At least 2 serotypes; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
At least 3 serotypes; Pre-injection 1 Number Analyzed 109 participants 107 participants
0.9 0.9
At least 3 serotypes; Post-injection 2 Number Analyzed 105 participants 103 participants
94.3 95.1
At least 3 serotypes; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
All 4 serotypes; Pre-injection 1 Number Analyzed 109 participants 107 participants
0.9 0.0
All 4 serotypes; Post-injection 2 Number Analyzed 105 participants 103 participants
79.0 89.3
All 4 serotypes; Post-injection 3 Number Analyzed 102 participants 98 participants
100.0 100.0
6.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine
Hide Description 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.
Time Frame Day 0 up to Day 14 post-first injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 309 315
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Tenderness Number Analyzed 308 participants 312 participants
29.9 33.3
Grade 3 Injection site Tenderness Number Analyzed 308 participants 312 participants
0.3 0.0
Injection site Erythema Number Analyzed 308 participants 312 participants
14.0 15.7
Grade 3 Injection site Erythema Number Analyzed 308 participants 312 participants
0.0 0.0
Injection site Swelling Number Analyzed 308 participants 312 participants
4.9 10.9
Grade 3 Injection site Swelling Number Analyzed 308 participants 312 participants
0.0 0.3
Fever Number Analyzed 307 participants 313 participants
25.1 28.1
Grade 3 Fever Number Analyzed 307 participants 313 participants
1.6 0.0
Vomiting Number Analyzed 308 participants 312 participants
18.8 17.6
Grade 3 Vomiting Number Analyzed 308 participants 312 participants
1.3 0.6
Crying abnormal Number Analyzed 308 participants 312 participants
36.4 38.5
Grade 3 Crying abnormal Number Analyzed 308 participants 312 participants
2.3 2.2
Drowsiness Number Analyzed 308 participants 312 participants
24.0 23.4
Grade 3 Drowsiness Number Analyzed 308 participants 312 participants
1.9 1.6
Appetite lost Number Analyzed 308 participants 311 participants
32.5 34.7
Grade 3 Appetite lost Number Analyzed 308 participants 311 participants
4.5 4.5
Injection site Irritability Number Analyzed 308 participants 312 participants
47.1 45.5
Grade 3 Injection site Irritability Number Analyzed 308 participants 312 participants
3.2 4.2
7.Secondary Outcome
Title 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
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 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.
Time Frame Day 0 up to Day 14 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 309 314
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Tenderness Number Analyzed 301 participants 305 participants
43.2 42.3
Grade 3 Injection site Tenderness Number Analyzed 301 participants 305 participants
1.0 0.7
Injection site Tenderness; Post- Pentaxim Number Analyzed 301 participants 305 participants
37.5 37.7
Grade 3 Injection site Tenderness; Post- Pentaxim Number Analyzed 301 participants 305 participants
1.0 0.7
Injection site Tenderness; Post-CYD dengue/placebo Number Analyzed 301 participants 305 participants
33.2 30.5
Grd 3 Inj. site Tenderness;Post-CYD dengue/placebo Number Analyzed 301 participants 305 participants
0.0 0.3
Injection site Erythema Number Analyzed 301 participants 305 participants
15.0 20.3
Grade 3 Injection site Erythema Number Analyzed 301 participants 305 participants
0.3 0.0
Injection site Erythema; Post-Pentaxim Number Analyzed 301 participants 304 participants
13.0 17.8
Grade 3 Injection site Erythema; Post- Pentaxim Number Analyzed 301 participants 304 participants
0.3 0.0
Injection site Erythema; Post-CYD dengue/placebo Number Analyzed 301 participants 305 participants
8.3 13.1
Grd 3 Inj. site Erythema; Post-CYD dengue/placebo Number Analyzed 301 participants 305 participants
0.0 0.0
Injection site Swelling Number Analyzed 301 participants 305 participants
11.6 17.0
Grade 3 Injection site Swelling Number Analyzed 301 participants 305 participants
0.3 0.0
Injection site Swelling; Post-Pentaxim Number Analyzed 299 participants 305 participants
9.4 16.1
Grade 3 Injection site Swelling; Post- Pentaxim Number Analyzed 299 participants 305 participants
0.3 0.0
Injection site Swelling; Post-CYD dengue/placebo Number Analyzed 301 participants 305 participants
5.0 7.2
Grd 3 Inj. site Swelling; Post-CYD dengue/placebo Number Analyzed 301 participants 305 participants
0.0 0.0
Injection site extensive swelling; Post- Pentaxim Number Analyzed 301 participants 306 participants
0.0 0.0
Grd 3 Inj. site extensive swelling; Post- Pentaxim Number Analyzed 301 participants 306 participants
0.0 0.0
Fever Number Analyzed 299 participants 300 participants
29.1 24.3
Grade 3 Fever Number Analyzed 299 participants 300 participants
1.0 0.0
Vomiting Number Analyzed 300 participants 305 participants
11.7 11.8
Grade 3 Vomiting Number Analyzed 300 participants 305 participants
1.0 0.0
Crying abnormal Number Analyzed 300 participants 305 participants
33.7 30.8
Grade 3 Crying abnormal Number Analyzed 300 participants 305 participants
0.7 1.6
Drowsiness Number Analyzed 300 participants 305 participants
19.7 17.0
Grade 3 Drowsiness Number Analyzed 300 participants 305 participants
1.0 0.7
Appetite lost Number Analyzed 300 participants 305 participants
23.3 23.0
Grade 3 Appetite lost Number Analyzed 300 participants 305 participants
3.7 3.0
Irritability Number Analyzed 300 participants 305 participants
37.7 39.7
Grade 3 Irritability Number Analyzed 300 participants 305 participants
1.0 0.7
8.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine
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 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.
Time Frame Day 0 up to Day 14 post-second injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 301 302
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Tenderness Number Analyzed 294 participants 296 participants
24.5 25.7
Grade 3 Injection site Tenderness Number Analyzed 294 participants 296 participants
0.0 0.0
Injection site Erythema Number Analyzed 294 participants 296 participants
8.2 10.1
Grade 3 Injection site Erythema Number Analyzed 294 participants 296 participants
0.0 0.0
Injection site Swelling Number Analyzed 294 participants 296 participants
4.4 5.1
Grade 3 Injection site Swelling Number Analyzed 294 participants 296 participants
0.0 0.3
Fever Number Analyzed 293 participants 293 participants
16.7 18.1
Grade 3 Fever Number Analyzed 293 participants 293 participants
0.0 0.7
Vomiting Number Analyzed 293 participants 296 participants
6.8 8.8
Grade 3 Vomiting Number Analyzed 293 participants 296 participants
0.3 0.0
Crying abnormal Number Analyzed 293 participants 296 participants
21.2 24.3
Grade 3 Crying abnormal Number Analyzed 293 participants 296 participants
0.0 0.3
Drowsiness Number Analyzed 293 participants 296 participants
11.9 14.9
Grade 3 Drowsiness Number Analyzed 293 participants 296 participants
0.0 0.0
Appetite lost Number Analyzed 293 participants 296 participants
17.7 20.9
Grade 3 Appetite lost Number Analyzed 293 participants 296 participants
1.7 1.7
Irritability Number Analyzed 293 participants 296 participants
23.9 25.3
Grade 3 Irritability Number Analyzed 293 participants 296 participants
0.3 1.0
9.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine
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 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.
Time Frame Day 0 up to Day 14 post-third injection
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 298 297
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Tenderness Number Analyzed 298 participants 291 participants
19.8 25.4
Grade 3 Injection site Tenderness Number Analyzed 298 participants 291 participants
0.0 0.0
Injection site Erythema Number Analyzed 298 participants 291 participants
6.7 5.8
Grade 3 Injection site Erythema Number Analyzed 298 participants 291 participants
0.0 0.0
Injection site Swelling Number Analyzed 298 participants 291 participants
2.0 2.7
Grade 3 Injection site Swelling Number Analyzed 298 participants 291 participants
0.0 0.0
Fever Number Analyzed 294 participants 289 participants
16.0 15.2
Grade 3 Fever Number Analyzed 294 participants 289 participants
1.0 0.0
Vomiting Number Analyzed 298 participants 291 participants
4.4 7.2
Grade 3 Vomiting Number Analyzed 298 participants 291 participants
0.7 1.0
Crying abnormal Number Analyzed 298 participants 291 participants
21.5 18.9
Grade 3 Crying abnormal Number Analyzed 298 participants 291 participants
0.7 0.3
Drowsiness Number Analyzed 298 participants 291 participants
10.4 10.0
Grade 3 Drowsiness Number Analyzed 298 participants 291 participants
0.7 0.7
Appetite lost Number Analyzed 298 participants 291 participants
18.8 18.6
Grade 3 Appetite lost Number Analyzed 298 participants 291 participants
1.3 2.4
Irritability Number Analyzed 298 participants 291 participants
23.8 20.6
Grade 3 Irritability Number Analyzed 298 participants 291 participants
1.0 0.0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months).
Adverse Event Reporting Description Analysis was performed on Safety analysis set.
 
Arm/Group Title CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Hide Arm/Group Description 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). 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).
All-Cause Mortality
CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/309 (0.00%)      1/315 (0.32%)    
Hide Serious Adverse Events
CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/309 (5.50%)      21/315 (6.67%)    
Blood and lymphatic system disorders     
Thrombocytopenic purpura * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Congenital, familial and genetic disorders     
Phimosis * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea * 1  1/309 (0.32%)  1 1/315 (0.32%)  1
Infections and infestations     
Amoebic dysentery * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Ascariasis * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Bronchopneumonia * 1  0/309 (0.00%)  0 2/315 (0.63%)  3
Cellulitis * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Dengue fever * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Gastroenteritis * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Gastroenteritis bacterial * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Gastroenteritis viral * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Pneumonia * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Injury, poisoning and procedural complications     
Accidental exposure * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Burns second degree * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Head injury * 1  1/309 (0.32%)  1 0/315 (0.00%)  0
Road traffic accident * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Thermal burn * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myelomonocytic leukaemia * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Nervous system disorders     
Encephalitis * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Febrile convulsion * 1  5/309 (1.62%)  6 7/315 (2.22%)  10
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Asthmatic crisis * 1  2/309 (0.65%)  2 1/315 (0.32%)  1
Bronchial hyperreactivity * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
Respiratory distress * 1  0/309 (0.00%)  0 1/315 (0.32%)  1
1
Term from vocabulary, MedDRA (11.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CYD Dengue Vaccine Group 1 CYD Dengue Vaccine Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   145/309 (46.93%)      142/315 (45.08%)    
Gastrointestinal disorders     
Diarrhoea * 1  34/309 (11.00%)  41 34/315 (10.79%)  37
Vomiting; Post-injection 1 † 1  58/308 (18.83%)  58 55/312 (17.63%)  55
General disorders     
Injection site Tenderness; Post-injection 1 † 1  92/309 (29.77%)  92 104/312 (33.33%)  104
Injection site Erythema; Post-injection 1 † 1  43/308 (13.96%)  43 49/312 (15.71%)  49
Injection site Swelling; Post-injection 1 † 1  15/308 (4.87%)  15 34/312 (10.90%)  34
Fever; Post-injection 1 † 1  77/307 (25.08%)  77 88/313 (28.12%)  88
Infections and infestations     
Gastroenteritis * 1  55/309 (17.80%)  61 47/315 (14.92%)  51
Nasopharyngitis * 1  109/309 (35.28%)  147 104/315 (33.02%)  132
Pharyngitis * 1  50/309 (16.18%)  60 57/315 (18.10%)  69
Pharyngotonsillitis * 1  24/309 (7.77%)  28 33/315 (10.48%)  33
Rhinitis * 1  25/309 (8.09%)  26 22/315 (6.98%)  26
Metabolism and nutrition disorders     
Appetite lost; Post-injection 1 † 1  100/308 (32.47%)  100 108/311 (34.73%)  108
Nervous system disorders     
Drowsiness; Post-injection 1 † 1  74/308 (24.03%)  74 73/312 (23.40%)  73
Psychiatric disorders     
Crying abnormal; Post-injection 1 † 1  112/308 (36.36%)  112 120/312 (38.46%)  120
Irritability; Post-injection 1 † 1  145/308 (47.08%)  145 142/312 (45.51%)  142
1
Term from vocabulary, MedDRA (11.0)
*
Indicates events were collected by non-systematic assessment
†
Indicates events were collected by systematic assessment
[Not Specified]
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 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.
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: NCT01411241    
Other Study ID Numbers: CYD33
U1111-1115-6290 ( Other Identifier: WHO )
First Submitted: August 3, 2011
First Posted: August 8, 2011
Results First Submitted: May 23, 2019
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019