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Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

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ClinicalTrials.gov Identifier: NCT01373281
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : November 16, 2015
Last Update Posted : December 17, 2018
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 Fever
Dengue Hemorrhagic Fever
Interventions Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
Biological: Placebo: Sodium chloride (NaCl) 0.9%
Enrollment 10275
Recruitment Details Study participants were enrolled from 03 June 2011 to 01 December 2011 at 9 sites in Indonesia, 5 in Malaysia, 3 in Thailand, 5 in Philippines, and 2 in Vietnam.
Pre-assignment Details A total of 10275 participants were enrolled; all but one met all of the inclusion criteria and none of the exclusion criteria. Three participants were not vaccinated and were excluded from the Full Analysis Set for Efficacy and the Safety Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months). Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).
Period Title: Vaccination Phase (Up to 25 Months)
Started 6851 3424
Completed 6797 3397
Not Completed 54 27
Reason Not Completed
Withdrawal by Subject             40             23
Protocol Violation             5             2
Lost to Follow-up             5             1
Serious adverse event             4             1
Period Title: Surveillance Expansion Period
Started 6797 3397
Completed 6595 3279
Not Completed 202 118
Reason Not Completed
Withdrawal by Subject             180             105
Protocol Violation             9             1
Lost to Follow-up             10             8
Serious adverse event             3             4
Arm/Group Title CYD Dengue Vaccine Group Placebo Group Total
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months). Participants received 3 doses of placebo vaccine, one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months). Total of all reporting groups
Overall Number of Baseline Participants 6851 3424 10275
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6851 participants 3424 participants 10275 participants
<=18 years
6851
 100.0%
3424
 100.0%
10275
 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:  Years
Age Continuous Number Analyzed 6851 participants 3424 participants 10275 participants
8.8  (3.45) 8.8  (3.42) 8.8  (3.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6851 participants 3424 participants 10275 participants
Female
3524
  51.4%
1767
  51.6%
5291
  51.5%
Male
3327
  48.6%
1657
  48.4%
4984
  48.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6851 participants 3424 participants 10275 participants
Philippines
2335
  34.1%
1166
  34.1%
3501
  34.1%
Malaysia
937
  13.7%
464
  13.6%
1401
  13.6%
Indonesia
1246
  18.2%
624
  18.2%
1870
  18.2%
Thailand
778
  11.4%
392
  11.4%
1170
  11.4%
Vietnam
1555
  22.7%
778
  22.7%
2333
  22.7%
1.Primary Outcome
Title Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection (Inj.) With Either CYD Dengue Vaccine or a Placebo
Hide Description Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS protein 1 antigen enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.
Time Frame 28 days and up to 13 months post-dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Number of symptomatic VCD cases were assessed in the Per-Protocol Analysis Set for Efficacy
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6709 3350
Measure Type: Number
Unit of Measure: Cases
117 133
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Placebo Group
Comments The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow & Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 56.5
Confidence Interval (2-Sided) 95%
43.8 to 66.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Hide Description Geometric mean titers against each of the 4 serotypes of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of participants.
Time Frame Pre-injection 1, 28 days post Injections 2 and 3, 13 months (Visit 07) and 60 months (Visit 12) post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in Full Analysis Set for Immunogenicity(FASI),which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here,‘number analyzed’=participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Subset of participants who received at least one dose of CYD Dengue vaccine.
Subset of participants who received at least one dose of the placebo vaccine.
Overall Number of Participants Analyzed 1323 660
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue virus Serotype 1; Pre-Inj. 1 Number Analyzed 1309 participants 655 participants
38.3
(33.8 to 43.5)
42.1
(35 to 50.6)
Dengue virus Serotype 1; Post Inj. 2 Number Analyzed 1317 participants 654 participants
153
(137 to 170)
46.1
(38.2 to 55.7)
Dengue virus Serotype 1; Post Inj. 3 Number Analyzed 1316 participants 657 participants
166
(150 to 183)
46.6
(38.7 to 56.1)
Dengue virus Serotype 1; Year 1 Post Inj. 3 (V 07) Number Analyzed 1290 participants 634 participants
105
(92.8 to 119)
57.2
(46.9 to 69.8)
Dengue virus Serotype 1; Year 5 Post Inj. 3 (V 12) Number Analyzed 1275 participants 640 participants
81.2
(72.5 to 91.0)
77.6
(65.4 to 92.2)
Dengue virus Serotype 2; Pre-Inj. 1 Number Analyzed 1313 participants 654 participants
55.3
(48.7 to 62.9)
62.1
(51.7 to 74.7)
Dengue virus Serotype 2; Post Inj. 2 Number Analyzed 1316 participants 655 participants
360
(329 to 394)
69.5
(57.7 to 83.6)
Dengue virus Serotype 2; Post Inj. 3 Number Analyzed 1314 participants 657 participants
355
(327 to 386)
68.5
(57.1 to 82.2)
Dengue virus Serotype 2; Year 1 Post-Inj. 3 (V 07) Number Analyzed 1298 participants 640 participants
194
(175 to 214)
78.1
(64.8 to 94.0)
Dengue virus Serotype 2; Year 5 Post-Inj. 3 (V 12) Number Analyzed 1275 participants 640 participants
144
(130 to 160)
102
(86.8 to 120)
Dengue virus Serotype 3; Pre-Inj. 1 Number Analyzed 1307 participants 650 participants
40.1
(35.6 to 45.1)
40.7
(34.5 to 48)
Dengue virus Serotype 3; Post Inj. 2 Number Analyzed 1313 participants 656 participants
203
(184 to 223)
40.8
(34.6 to 48.1)
Dengue virus Serotype 3; Post Inj. 3 Number Analyzed 1314 participants 657 participants
207
(189 to 226)
42.5
(36.2 to 49.9)
Dengue virus Serotype 3; Year 1 Post Inj. 3 (V 07) Number Analyzed 1298 participants 639 participants
186
(168 to 206)
62.1
(51.8 to 74.6)
Dengue virus Serotype 3; Year 5 Post Inj. 3 (V 12) Number Analyzed 1275 participants 640 participants
120
(108 to 133)
76.2
(65.3 to 89.0)
Dengue virus Serotype 4; Pre Inj. 1 Number Analyzed 1313 participants 653 participants
25.3
(22.9 to 28)
26.2
(22.6 to 30.3)
Dengue virus Serotype 4; Post Inj. 2 Number Analyzed 1318 participants 655 participants
151
(139 to 163)
24.4
(21.3 to 28.1)
Dengue virus Serotype 4; Post Inj. 3 Number Analyzed 1315 participants 657 participants
151
(141 to 162)
26.0
(22.6 to 29.8)
Dengue virus Serotype 4; Year 1 Post Inj. 3 (V 07) Number Analyzed 1293 participants 621 participants
85.5
(78.5 to 93)
26.0
(22.4 to 30.3)
Dengue virus Serotype 4; Year 5 Post Inj. 3 (V 12) Number Analyzed 1275 participants 640 participants
65.7
(60.3 to 71.6)
40.1
(34.8 to 46.1)
3.Secondary Outcome
Title Percentage of Participants With Antibody Titers >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain Before and Following Inj. With CYD Dengue Vaccine or Placebo
Hide Description Percentage of participants with antibody titers >= 10 (1/Dil) against each serotypes of the dengue virus strains were assessed using PRNT in a pre-defined subset of participants.
Time Frame Pre-injection 1, 28 days post Injections 2 and 3, 13 months (V 07) and 60 months (V 12) post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in FASI, which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Subset of participants who received at least one dose of CYD Dengue vaccine
Subset of participants who received at least one dose of placebo vaccine
Overall Number of Participants Analyzed 1323 660
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue virus Serotype 1; Pre-Inj. 1 Number Analyzed 1309 participants 655 participants
52.0 51.3
Dengue virus Serotype 1; Post Inj. 2 Number Analyzed 1317 participants 654 participants
88.9 54.4
Dengue virus Serotype 1; Post-Inj. 3 Number Analyzed 1316 participants 657 participants
94.0 55.4
Dengue virus Serotype 1; Year 1 Post-Inj. 3 (V 07) Number Analyzed 1290 participants 634 participants
79.8 55.7
Dengue virus Serotype 1; Year 5 Post-Inj 3 (V 12) Number Analyzed 1275 participants 640 participants
76.2 70.0
Dengue virus Serotype 2; Pre-Inj. 1 Number Analyzed 1313 participants 654 participants
58.0 59.3
Dengue virus Serotype 2; Post-Inj. 2 Number Analyzed 1316 participants 655 participants
97.3 62.4
Dengue virus Serotype 2; Post-Inj. 3 Number Analyzed 1314 participants 657 participants
98.7 61.8
Dengue virus Serotype 2; Year 1 Post-Inj. 3 (V 07) Number Analyzed 1298 participants 640 participants
92.0 65.8
Dengue virus Serotype 2; Year 5 Post-inj 3 (V 12) Number Analyzed 1275 participants 640 participants
86 75.2
Dengue virus Serotype 3; Pre-Inj. 1 Number Analyzed 1307 participants 650 participants
56.8 59.4
Dengue virus Serotype 3; Post-Inj. 2 Number Analyzed 1313 participants 656 participants
95.7 60.2
Dengue virus Serotype 3; Post-Inj. 3 Number Analyzed 1314 participants 657 participants
97.0 61.0
Dengue virus Serotype 3; Year 1 Post-Inj. 3 (V 07) Number Analyzed 1298 participants 639 participants
93.6 62.6
Dengue virus Serotype 3; Year5 Post-Inj. 3 (V 12) Number Analyzed 1275 participants 640 participants
87.4 75.6
Dengue virus Serotype 4; Pre-Inj. 1 Number Analyzed 1313 participants 653 participants
51.6 50.7
Dengue virus Serotype 4; Post-Inj. 2 Number Analyzed 1318 participants 655 participants
95.1 51.8
Dengue virus Serotype 4; Post-Inj. 3 Number Analyzed 1315 participants 657 participants
97.0 53.9
Dengue virus Serotype 4; Year 1 Post-Inj 3 (V 07) Number Analyzed 1293 participants 621 participants
89.4 50.6
Dengue virus Serotype 4; Year 5 Post-Inj 3 (V 12) Number Analyzed 1275 participants 640 participants
83.8 65.0
4.Secondary Outcome
Title Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo
Hide Description Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.
Time Frame 28 days post-injection 1 and up to 13 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included participants who received at least 1 dose of study vaccine.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6848 3424
Measure Type: Number
Unit of Measure: Cases
276 302
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Placebo Group
Comments The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 55.4
Confidence Interval (2-Sided) 95%
47.3 to 62.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Symptomatic VCD Cases Due to Any Serotype 28 Days Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo
Hide Description Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.
Time Frame 28 days post-injection 2 and up to 13 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Number of symptomatic VCD cases were assessed in the Other Efficacy Analysis Set, which included participants who received at least 2 doses of study vaccine.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6793 3397
Measure Type: Number
Unit of Measure: Cases
205 238
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Placebo Group
Comments The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 57.9
Confidence Interval (2-Sided) 95%
49.0 to 65.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase in Either CYD Dengue Vaccine or Placebo Group
Hide Description Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.
Time Frame Day 0 up to 13 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included all participants who received at least 1 injection.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6848 3424
Measure Type: Number
Unit of Measure: Cases
286 309
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Placebo Group
Comments The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 54.8
Confidence Interval (2-Sided) 95%
46.8 to 61.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Symptomatic VCD Cases Meeting 1997 WHO Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
Hide Description

Dengue hemorrhagic fever cases were defined as number of participants with at least one symptomatic VCD episode meeting the 1997 WHO criteria.

(a) Fever: acute onset, high (>= 38°C) and continuous, lasting 2 to 7 days and (b) any of the pre-listed hemorrhagic manifestations and laboratory findings of thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hemoconcentation (hematocrit increased by 20% or more) or pleural effusion (seen on CXR) and/or ascites and/or hypoaluminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish a clinical diagnosis of DHF. Dengue hemorrhagic fever was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhage.

Time Frame Day 0 to the end of study (up to 72 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of WHO dengue hemorrhagic fever cases were assessed in the Safety Analysis Set, which included all participants who received at least one dose of study vaccine. 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 were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6848 3424
Measure Type: Number
Unit of Measure: Cases
Due to Any of the 4 Serotypes: Any Grade Number Analyzed 6745 participants 3369 participants
55 41
Due to Any of the 4 Serotypes: Grade I Number Analyzed 6745 participants 3369 participants
14 9
Due to Any of the 4 Serotypes: Grade II Number Analyzed 6745 participants 3369 participants
37 29
Due to Any of the 4 Serotypes: Grade III Number Analyzed 6745 participants 3369 participants
4 3
Due to Any of the 4 Serotypes: Grade IV Number Analyzed 6745 participants 3369 participants
0 0
8.Secondary Outcome
Title Number of Symptomatic VCD Cases Meeting 1997 WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Inj. With Either CYD Dengue Vaccine or a Placebo
Hide Description The 1997 WHO criteria are: a) Fever: acute onset, high (>= 38°C) and continuous, for 2 to 7 days and (b) any of the following: thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hematocrit increased by 20% or more or pleural effusion and/or ascites and/or hypoaluminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish diagnosis of DHF. Dengue hemorrhagic fever was graded as follows:Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participant,usually in the form of skin and/or other hemorrhages; Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse.
Time Frame From consent to participate int the Surveillance Expansion Period to 60 months post-injection 3 (up to Month 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of WHO dengue hemorrhagic fever cases were assessed in the Full Analysis Set for Surveillance Expansion Period, which included all participants who received at least 1 injection and accepted to be included in the Surveillance Expansion Period.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participant were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6327 3138
Measure Type: Number
Unit of Measure: Cases
Due to Any of the 4 Serotypes: Any Grade 19 12
Due to Any of the 4 Serotypes: Grade I 5 3
Due to Any of the 4 Serotypes: Grade II 11 8
Due to Any of the 4 Serotypes: Grade III 3 1
Due to Any of the 4 Serotypes: Grade IV 0 0
9.Secondary Outcome
Title Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Inj. With Either CYD Dengue Vaccine or a Placebo
Hide Description The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:1) Platelet count <=100000 μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20 mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST >1000 IU/L or PT INR >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.
Time Frame Day 0 to the end of study (up to 72 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of clinically severe VCD cases were assessed in the Safety 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 were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participant were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6745 3369
Measure Type: Number
Unit of Measure: Cases
61 41
10.Secondary Outcome
Title Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Inj. With Either CYD Dengue Vaccine or a Placebo
Hide Description The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:1) Platelet count <=100000μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST >1000 IU/L or PT INR >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.
Time Frame From consent to participate in the Surveillance Expansion Period to 60 months post-injection 3 (up to Month 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of clinically severe VCD cases were assessed in the Full Analysis Set for SEP.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participant were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 6327 3138
Measure Type: Number
Unit of Measure: Cases
21 12
11.Secondary Outcome
Title Number of Participants With Solicited Injection Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, >= 50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm.
Time Frame Within 7 days after injection
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 1334 663
Measure Type: Number
Unit of Measure: participants
Injection-site Pain (Post any injection) Number Analyzed 1332 participants 663 participants
614 275
Injection-site Erythema (Post-any injection) Number Analyzed 1332 participants 663 participants
107 52
Injection-site Swelling (Post any injection) Number Analyzed 1332 participants 663 participants
68 33
Injection-site Pain (Post-injection 1) Number Analyzed 1332 participants 663 participants
406 196
Grade 3 Injection-site Pain (Post-injection 1) Number Analyzed 1332 participants 663 participants
1 0
Injection-site Erythema (Post-injection 1) Number Analyzed 1332 participants 663 participants
63 35
Grade 3 Injection-site Erythema (Post-injection 1) Number Analyzed 1332 participants 663 participants
0 0
Injection-site Swelling (Post-injection 1) Number Analyzed 1332 participants 663 participants
40 19
Grade 3 Injection-site Swelling (Post-injection 1) Number Analyzed 1332 participants 663 participants
0 0
Injection-site Pain (Post-injection 2) Number Analyzed 1319 participants 658 participants
303 135
Grade 3 Injection-site Pain (Post-injection 2) Number Analyzed 1319 participants 658 participants
0 0
Injection-site Erythema (Post-injection 2) Number Analyzed 1319 participants 658 participants
43 20
Grade 3 Injection-site Erythema (Post-injection 2) Number Analyzed 1319 participants 658 participants
0 0
Injection-site Swelling (Post-injection 2) Number Analyzed 1319 participants 658 participants
25 7
Grade 3 Injection-site Swelling (Post-injection 2) Number Analyzed 1319 participants 658 participants
0 0
Injection-site Pain (Post-injection 3) Number Analyzed 1313 participants 654 participants
283 118
Grade 3 Injection-site Pain (Post-injection 3) Number Analyzed 1313 participants 654 participants
0 0
Injection-site Erythema (Post-injection 3) Number Analyzed 1313 participants 654 participants
36 16
Grade 3 Injection-site Erythema (Post-injection 3) Number Analyzed 1313 participants 654 participants
0 1
Injection-site Swelling (Post-injection 3) Number Analyzed 1313 participants 654 participants
19 10
Grade 3 Injection-site Swelling (Post-injection 3) Number Analyzed 1313 participants 654 participants
0 0
12.Secondary Outcome
Title Number of Participants With Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo
Hide Description Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever, >= 39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.
Time Frame Within 14 days after injection
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited systemic reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
Participants were to receive 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 1334 663
Measure Type: Number
Unit of Measure: participants
Fever (Post any injection) Number Analyzed 1332 participants 663 participants
248 118
Headache (Post any injection) Number Analyzed 1332 participants 663 participants
562 259
Malaise (Post any injection) Number Analyzed 1332 participants 663 participants
476 239
Myalgia (Post any injection) Number Analyzed 1332 participants 663 participants
414 197
Asthenia (Post any injection) Number Analyzed 1332 participants 663 participants
378 167
Fever (Post-injection 1) Number Analyzed 1330 participants 663 participants
103 45
Grade 3 Fever (Post-injection 1) Number Analyzed 1330 participants 663 participants
18 7
Headache (Post-injection 1) Number Analyzed 1332 participants 663 participants
387 168
Grade 3 Headache (Post-injection 1) Number Analyzed 1332 participants 663 participants
7 6
Malaise (Post-injection 1) Number Analyzed 1332 participants 663 participants
312 148
Grade 3 Malaise (Post-injection 1) Number Analyzed 1332 participants 663 participants
7 4
Myalgia (Post-injection 1) Number Analyzed 1332 participants 663 participants
255 124
Grade 3 Myalgia (Post-injection 1) Number Analyzed 1332 participants 663 participants
2 2
Asthenia (Post-injection 1) Number Analyzed 1332 participants 663 participants
229 97
Grade 3 Asthenia (Post-injection 1) Number Analyzed 1332 participants 663 participants
5 5
Fever (Post-injection 2) Number Analyzed 1320 participants 657 participants
90 44
Grade 3 Fever (Post-injection 2) Number Analyzed 1320 participants 657 participants
19 9
Headache (Post-injection 2) Number Analyzed 1319 participants 658 participants
247 118
Grade 3 Headache (Post-injection 2) Number Analyzed 1319 participants 658 participants
12 3
Malaise (Post-injection 2) Number Analyzed 1319 participants 658 participants
192 100
Grade 3 Malaise (Post-injection 2) Number Analyzed 1319 participants 658 participants
6 4
Myalgia (Post-injection 2) Number Analyzed 1319 participants 658 participants
174 92
Grade 3 Myalgia (Post-injection 2) Number Analyzed 1319 participants 658 participants
3 0
Asthenia (Post-injection 2) Number Analyzed 1319 participants 658 participants
158 74
Grade 3 Asthenia (Post-injection 2) Number Analyzed 1319 participants 658 participants
5 6
Fever (Post-injection 3) Number Analyzed 1309 participants 654 participants
76 39
Grade 3 Fever (Post-injection 3) Number Analyzed 1309 participants 654 participants
16 2
Headache (Post-injection 3) Number Analyzed 1313 participants 654 participants
219 113
Grade 3 Headache (Post-injection 3) Number Analyzed 1313 participants 654 participants
6 1
Malaise (Post-injection 3) Number Analyzed 1313 participants 654 participants
183 104
Grade 3 Malaise (Post-injection 3) Number Analyzed 1313 participants 654 participants
7 1
Myalgia (Post-injection 3) Number Analyzed 1313 participants 654 participants
156 76
Grade 3 Myalgia (Post-injection 3) Number Analyzed 1313 participants 654 participants
3 0
Asthenia (Post-injection 3) Number Analyzed 1313 participants 654 participants
142 73
Grade 3 Asthenia (Post-injection 3) Number Analyzed 1313 participants 654 participants
4 2
13.Secondary Outcome
Title Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
Hide Description Hospitalized VCD cases were defined as VCD confirmed by dengue RT–PCR and/or dengue NS1 ELISA in participants with acute febrile illness (temperature >=38°C on at least 2 consecutive days) requiring hospitalization.
Time Frame Day 0 to the end of study (up to 72 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (up to 72 months).
Participants were to receive 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (up to 72 months).
Overall Number of Participants Analyzed 6745 3369
Measure Type: Number
Unit of Measure: Cases
210 154
14.Secondary Outcome
Title Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo
Hide Description Hospitalized VCD cases were defined as VCD confirmed by dengue RT–PCR and/or dengue NS1 ELISA in participants with acute febrile illness (temperature >= 38°C on at least 2 consecutive days) requiring hospitalization.
Time Frame From consent to participate in the Surveillance Expansion Period to 60 months post-injection 3 (up to Month 72)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (up to 72 months).
Participants were to receive 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (up to 72 months).
Overall Number of Participants Analyzed 6848 3424
Measure Type: Number
Unit of Measure: Cases
74 48
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to 60 months post-injection 3 (up to 72 months).
Adverse Event Reporting Description All the vaccinated participants were assessed for SAE during the trial. Non-serious adverse events included solicited injection-site (within 7 days after injection) and solicited systemic reactions (within 14 days after injection), as well as unsolicited non-serious adverse events (within 28 days after injection). These events were assessed in a subset of participants from each group, who had received at least 1 dose of study vaccine.
 
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months. Participants were to receive 3 doses of placebo vaccine; one each at 0, 6, and 12 months.
All-Cause Mortality
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   10/6848 (0.15%)      4/3424 (0.12%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   947/6848 (13.83%)      552/3424 (16.12%)    
Blood and lymphatic system disorders     
Anaemia  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Anaemia Of Pregnancy  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Haemorrhagic Anaemia  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Iron Deficiency Anaemia  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Lymphadenitis  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Cardiac disorders     
Cardiac Failure Congestive  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Cardiogenic Shock  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Rheumatic Heart Disease  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Supraventricular Tachycardia  1  1/6848 (0.01%)  2 1/3424 (0.03%)  1
Ventricular Tachycardia  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Congenital, familial and genetic disorders     
Cryptorchism  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Duchenne Muscular Dystrophy  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Familial Periodic Paralysis  1  1/6848 (0.01%)  2 0/3424 (0.00%)  0
Fibrous Dysplasia Of Bone  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Odontogenic Cyst  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Phimosis  1  0/6848 (0.00%)  0 2/3424 (0.06%)  2
Ear and labyrinth disorders     
Middle Ear Effusion  1  0/6848 (0.00%)  0 1/3424 (0.03%)  2
Vertigo Positional  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Vestibular Disorder  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Endocrine disorders     
Goitre  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Eye disorders     
Chalazion  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Choroidal Dystrophy  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Corneal Oedema  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Abdominal Pain Lower  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Abdominal Pain Upper  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Anal Fistula  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Caecitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Colitis  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Dental Caries  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Diarrhoea  1  6/6848 (0.09%)  6 6/3424 (0.18%)  6
Dyspepsia  1  8/6848 (0.12%)  8 2/3424 (0.06%)  2
Enteritis  1  5/6848 (0.07%)  5 1/3424 (0.03%)  2
Enterocolitis  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Food Poisoning  1  9/6848 (0.13%)  9 3/3424 (0.09%)  3
Gastritis  1  31/6848 (0.45%)  32 14/3424 (0.41%)  16
Gastrointestinal Disorder  1  9/6848 (0.13%)  10 5/3424 (0.15%)  5
Gastrointestinal Haemorrhage  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Gastrointestinal Inflammation  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Gastrooesophageal Reflux Disease  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Haemorrhoids  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Ileus  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Inguinal Hernia  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Mouth Cyst  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Pancreatitis Acute  1  1/6848 (0.01%)  2 0/3424 (0.00%)  0
Pancreatitis Chronic  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Periodontitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Peritonitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Salivary Gland Calculus  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Salivary Gland Mucocoele  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Tooth Development Disorder  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Tooth Impacted  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Toothache  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
General disorders     
Drowning  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Hernia Obstructive  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Pyrexia  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Hepatobiliary disorders     
Hepatitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Immune system disorders     
Allergy To Arthropod Bite  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Allergy To Arthropod Sting  1  4/6848 (0.06%)  4 1/3424 (0.03%)  1
Anaphylactic Reaction  1  3/6848 (0.04%)  3 1/3424 (0.03%)  1
Anaphylactic Shock  1  1/6848 (0.01%)  1 2/3424 (0.06%)  2
Drug Hypersensitivity  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Food Allergy  1  5/6848 (0.07%)  5 1/3424 (0.03%)  1
Hypersensitivity  1  2/6848 (0.03%)  2 2/3424 (0.06%)  2
Infections and infestations     
Abscess Limb  1  4/6848 (0.06%)  4 0/3424 (0.00%)  0
Abscess Neck  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Abscess Of External Auditory Meatus  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Acinetobacter Bacteraemia  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Acute Sinusitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Acute Tonsillitis  1  7/6848 (0.10%)  7 2/3424 (0.06%)  2
Adenoiditis  1  4/6848 (0.06%)  4 1/3424 (0.03%)  1
Amoebiasis  1  9/6848 (0.13%)  9 4/3424 (0.12%)  4
Amoebic Dysentery  1  3/6848 (0.04%)  3 2/3424 (0.06%)  2
Anal Abscess  1  0/6848 (0.00%)  0 2/3424 (0.06%)  2
Appendiceal Abscess  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Appendicitis  1  33/6848 (0.48%)  33 27/3424 (0.79%)  27
Appendicitis Perforated  1  5/6848 (0.07%)  5 4/3424 (0.12%)  4
Bacterial Diarrhoea  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Bacterial Infection  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Bartholin's Abscess  1  2/6848 (0.03%)  3 0/3424 (0.00%)  0
Bronchiolitis  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Bronchitis  1  16/6848 (0.23%)  16 6/3424 (0.18%)  8
Bronchitis Bacterial  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Bronchopneumonia  1  8/6848 (0.12%)  8 1/3424 (0.03%)  1
Brucellosis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Cellulitis  1  7/6848 (0.10%)  7 3/3424 (0.09%)  3
Chikungunya Virus Infection  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Chronic Tonsillitis  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Conjunctivitis Infective  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Cystitis  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Dengue Fever  1  238/6848 (3.48%)  241 158/3424 (4.61%)  167
Diarrhoea Infectious  1  3/6848 (0.04%)  3 5/3424 (0.15%)  5
Disseminated Tuberculosis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Encephalitis Viral  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Endophthalmitis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Furuncle  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Gastritis Bacterial  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Gastroenteritis  1  53/6848 (0.77%)  64 40/3424 (1.17%)  43
Gastroenteritis Bacterial  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Gastroenteritis Viral  1  3/6848 (0.04%)  3 1/3424 (0.03%)  1
Gastrointestinal Bacterial Infection  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Gastrointestinal Infection  1  6/6848 (0.09%)  6 5/3424 (0.15%)  5
Groin Abscess  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Hiv Infection  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Hand-Foot-And-Mouth Disease  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Hepatitis A  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Hepatitis Viral  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Herpangina  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Herpes Zoster  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Hordeolum  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Infection In An Immunocompromised Host  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Influenza  1  9/6848 (0.13%)  9 3/3424 (0.09%)  4
Leptospirosis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Lobar Pneumonia  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Lymphadenitis Bacterial  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Malaria  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Measles  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Meningitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Meningitis Aseptic  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Meningitis Bacterial  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Mumps  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Nasopharyngitis  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Oral Herpes  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Orchitis  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Otitis Externa  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Otitis Media  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Otitis Media Chronic  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Paratyphoid Fever  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Parotitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Periorbital Cellulitis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Peritonsillar Abscess  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Pharyngitis  1  32/6848 (0.47%)  35 19/3424 (0.55%)  25
Pharyngitis Bacterial  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Pharyngitis Streptococcal  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Pharyngotonsillitis  1  15/6848 (0.22%)  15 4/3424 (0.12%)  4
Plasmodium Falciparum Infection  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Pneumonia  1  33/6848 (0.48%)  37 12/3424 (0.35%)  12
Pneumonia Bacterial  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Pneumonia Measles  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Pneumonia Primary Atypical  1  2/6848 (0.03%)  2 2/3424 (0.06%)  2
Pneumonia Viral  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Postoperative Wound Infection  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Pulmonary Tuberculosis  1  5/6848 (0.07%)  5 2/3424 (0.06%)  2
Pyelonephritis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Pyelonephritis Acute  1  4/6848 (0.06%)  4 3/3424 (0.09%)  3
Respiratory Tract Infection  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Scarlet Fever  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Sepsis  1  2/6848 (0.03%)  2 2/3424 (0.06%)  2
Sinusitis  1  4/6848 (0.06%)  4 2/3424 (0.06%)  2
Staphylococcal Sepsis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Streptococcal Infection  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Tonsillitis  1  12/6848 (0.18%)  12 4/3424 (0.12%)  4
Tonsillitis Bacterial  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Tooth Abscess  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Tuberculosis  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Tuberculous Pleurisy  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Typhoid Fever  1  15/6848 (0.22%)  18 13/3424 (0.38%)  13
Typhus  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Upper Respiratory Tract Infection  1  11/6848 (0.16%)  11 5/3424 (0.15%)  6
Urethritis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Urinary Tract Infection  1  22/6848 (0.32%)  23 14/3424 (0.41%)  17
Varicella  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Viral Infection  1  32/6848 (0.47%)  35 29/3424 (0.85%)  29
Viral Pharyngitis  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Viral Rash  1  0/6848 (0.00%)  0 3/3424 (0.09%)  3
Viral Upper Respiratory Tract Infection  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Vulval Abscess  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Wound Infection  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Injury, poisoning and procedural complications     
Accident  1  4/6848 (0.06%)  4 1/3424 (0.03%)  1
Adverse Event Following Immunisation  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Animal Bite  1  2/6848 (0.03%)  2 4/3424 (0.12%)  4
Arthropod Bite  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Burns Second Degree  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Chemical Poisoning  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Chest Injury  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Clavicle Fracture  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Concussion  1  7/6848 (0.10%)  7 2/3424 (0.06%)  2
Contusion  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Ear Injury  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Electrical Burn  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Excoriation  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Eye Injury  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Eyeball Rupture  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Facial Bones Fracture  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Fall  1  15/6848 (0.22%)  16 6/3424 (0.18%)  6
Femur Fracture  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Fibula Fracture  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Foot Fracture  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Forearm Fracture  1  9/6848 (0.13%)  9 4/3424 (0.12%)  4
Foreign Body  1  5/6848 (0.07%)  5 0/3424 (0.00%)  0
Foreign Body In Eye  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Genital Injury  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Gun Shot Wound  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Hand Fracture  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Head Injury  1  5/6848 (0.07%)  5 4/3424 (0.12%)  4
Humerus Fracture  1  9/6848 (0.13%)  9 2/3424 (0.06%)  2
Impacted Fracture  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Injury  1  1/6848 (0.01%)  1 2/3424 (0.06%)  2
Intentional Overdose  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Joint Dislocation  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Joint Injury  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Laceration  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Ligament Sprain  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Limb Injury  1  1/6848 (0.01%)  1 3/3424 (0.09%)  3
Lower Limb Fracture  1  1/6848 (0.01%)  1 2/3424 (0.06%)  2
Multiple Fractures  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Multiple Injuries  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Muscle Strain  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Near Drowning  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Open Wound  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Overdose  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Poisoning Deliberate  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Postoperative Adhesion  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Postoperative Ileus  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Radius Fracture  1  6/6848 (0.09%)  6 5/3424 (0.15%)  5
Road Traffic Accident  1  71/6848 (1.04%)  75 38/3424 (1.11%)  39
Scrotal Haematoma  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Snake Bite  1  4/6848 (0.06%)  4 0/3424 (0.00%)  0
Soft Tissue Injury  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Sports Injury  1  5/6848 (0.07%)  5 1/3424 (0.03%)  1
Stab Wound  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Tendon Rupture  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Thermal Burn  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Tibia Fracture  1  1/6848 (0.01%)  1 2/3424 (0.06%)  2
Toxicity To Various Agents  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Tracheal Injury  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Traumatic Brain Injury  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Traumatic Intracranial Haemorrhage  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Upper Limb Fracture  1  3/6848 (0.04%)  3 2/3424 (0.06%)  2
Metabolism and nutrition disorders     
Calcium Deficiency  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Hypocalcaemia  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Hypoglycaemia  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Hypokalaemia  1  2/6848 (0.03%)  3 1/3424 (0.03%)  1
Musculoskeletal and connective tissue disorders     
Bone Cyst  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Exostosis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Fasciitis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Fracture Malunion  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Jaw Cyst  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Muscle Spasms  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Myositis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Rheumatic Fever  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Synovial Cyst  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Synovitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Lymphocytic Leukaemia  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Angiofibroma  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Benign Neoplasm Of Skin  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Benign Soft Tissue Neoplasm  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Bone Giant Cell Tumour Benign  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Bone Sarcoma  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Breast Neoplasm  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Ear Neoplasm  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Fibroadenoma Of Breast  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Fibrous Histiocytoma  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Haemangioma  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Lip Neoplasm Benign  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Lipoma  1  0/6848 (0.00%)  0 2/3424 (0.06%)  2
Lymphangioma  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Skin Papilloma  1  0/6848 (0.00%)  0 2/3424 (0.06%)  2
Soft Tissue Neoplasm  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Teratoma  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Nervous system disorders     
Acute Disseminated Encephalomyelitis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Autonomic Neuropathy  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Cerebral Venous Thrombosis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Complex Partial Seizures  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Convulsion  1  4/6848 (0.06%)  4 2/3424 (0.06%)  2
Convulsions Local  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Encephalitis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Epilepsy  1  8/6848 (0.12%)  9 4/3424 (0.12%)  7
Extrapyramidal Disorder  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Febrile Convulsion  1  13/6848 (0.19%)  23 7/3424 (0.20%)  7
Grand Mal Convulsion  1  2/6848 (0.03%)  3 0/3424 (0.00%)  0
Guillain-Barre Syndrome  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Intercostal Neuralgia  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Ischaemic Stroke  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Migraine Without Aura  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Partial Seizures  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Presyncope  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Status Epilepticus  1  1/6848 (0.01%)  2 0/3424 (0.00%)  0
Syncope  1  2/6848 (0.03%)  3 0/3424 (0.00%)  0
Tension Headache  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Tonic Convulsion  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Viith Nerve Paralysis  1  3/6848 (0.04%)  3 0/3424 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion Complete  1  3/6848 (0.04%)  4 0/3424 (0.00%)  0
Abortion Incomplete  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Abortion Spontaneous  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Abortion Spontaneous Incomplete  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Abortion Threatened  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Breech Presentation  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Cephalo-Pelvic Disproportion  1  3/6848 (0.04%)  3 1/3424 (0.03%)  1
Eclampsia  1  3/6848 (0.04%)  3 1/3424 (0.03%)  1
Ectopic Pregnancy  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
False Labour  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Foetal Distress Syndrome  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Oligohydramnios  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Postpartum Haemorrhage  1  0/6848 (0.00%)  0 2/3424 (0.06%)  2
Premature Labour  1  4/6848 (0.06%)  4 2/3424 (0.06%)  2
Puerperal Pyrexia  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Stillbirth  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Psychiatric disorders     
Abnormal Behaviour  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Acute Psychosis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Bipolar I Disorder  1  0/6848 (0.00%)  0 1/3424 (0.03%)  2
Bipolar Disorder  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Mental Disorder  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Psychosomatic Disease  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Psychotic Disorder  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Schizophrenia  1  2/6848 (0.03%)  2 1/3424 (0.03%)  2
Somatoform Disorder  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Suicide Attempt  1  1/6848 (0.01%)  1 2/3424 (0.06%)  2
Renal and urinary disorders     
Calculus Ureteric  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Glomerulonephritis Acute  1  3/6848 (0.04%)  3 1/3424 (0.03%)  1
Nephrotic Syndrome  1  2/6848 (0.03%)  4 0/3424 (0.00%)  0
Neurogenic Bladder  1  0/6848 (0.00%)  0 1/3424 (0.03%)  3
Post Streptococcal Glomerulonephritis  1  9/6848 (0.13%)  9 3/3424 (0.09%)  3
Renal Failure Acute  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Renal Tubular Acidosis  1  1/6848 (0.01%)  2 0/3424 (0.00%)  0
Reproductive system and breast disorders     
Acquired Phimosis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Breast Mass  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Dysfunctional Uterine Bleeding  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Endometriosis  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Haemorrhagic Ovarian Cyst  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Ovarian Cyst  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Ovarian Haemorrhage  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Uterine Cervical Erosion  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Uterine Haemorrhage  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Vaginal Haematoma  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adenoidal Hypertrophy  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Asphyxia  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Asthma  1  12/6848 (0.18%)  19 9/3424 (0.26%)  9
Bronchial Hyperreactivity  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Nasal Polyps  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Nasal Septum Deviation  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Neonatal Asphyxia  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Pneumothorax  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Respiratory Acidosis  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Sleep Apnoea Syndrome  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Upper Respiratory Tract Inflammation  1  2/6848 (0.03%)  2 0/3424 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema  1  2/6848 (0.03%)  2 1/3424 (0.03%)  1
Dermal Cyst  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Henoch-Schonlein Purpura  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Skin Hypertrophy  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Urticaria  1  1/6848 (0.01%)  1 2/3424 (0.06%)  2
Social circumstances     
Child Abuse  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Physical Assault  1  4/6848 (0.06%)  4 1/3424 (0.03%)  1
Victim Of Child Abuse  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Victim Of Crime  1  1/6848 (0.01%)  1 1/3424 (0.03%)  1
Victim Of Sexual Abuse  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Surgical and medical procedures     
Abortion Induced  1  1/6848 (0.01%)  1 0/3424 (0.00%)  0
Vascular disorders     
Aneurysm Ruptured  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Haematoma  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
Hypertension  1  0/6848 (0.00%)  0 1/3424 (0.03%)  1
1
Term from vocabulary, MedDra 14.0
Indicates events were collected by 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   942/1334 (70.61%)      453/663 (68.33%)    
General disorders     
Asthenia  1  378/1334 (28.34%)  530 167/663 (25.19%)  244
Injection Site Erythema  1  107/1334 (8.02%)  142 52/663 (7.84%)  71
Injection Site Pain  1  616/1334 (46.18%)  994 275/663 (41.48%)  449
Injection Site Swelling  1  68/1334 (5.10%)  84 33/663 (4.98%)  36
Malaise  1  476/1334 (35.68%)  689 239/663 (36.05%)  352
Pyrexia  1  267/1334 (20.01%)  291 125/663 (18.85%)  137
Infections and infestations     
Nasopharyngitis  1  85/1334 (6.37%)  113 45/663 (6.79%)  61
Upper Respiratory Tract Infection  1  95/1334 (7.12%)  104 54/663 (8.14%)  62
Musculoskeletal and connective tissue disorders     
Myalgia  1  414/1334 (31.03%)  585 197/663 (29.71%)  296
Nervous system disorders     
Headache  1  567/1334 (42.50%)  866 264/663 (39.82%)  409
Respiratory, thoracic and mediastinal disorders     
Cough  1  63/1334 (4.72%)  69 48/663 (7.24%)  61
Rhinorrhoea  1  46/1334 (3.45%)  48 36/663 (5.43%)  43
1
Term from vocabulary, MedDra 14.0
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: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: Contact-US@sanofi.com
Publications of Results:
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01373281     History of Changes
Other Study ID Numbers: CYD14
UTN: U1111-1116-4957 ( Other Identifier: WHO )
2014-001708-24 ( EudraCT Number )
First Submitted: June 8, 2011
First Posted: June 14, 2011
Results First Submitted: September 15, 2015
Results First Posted: November 16, 2015
Last Update Posted: December 17, 2018