Trial Outcomes & Findings for Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers (NCT NCT01436396)
NCT ID: NCT01436396
Last Updated: 2022-03-25
Results Overview
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
792 participants
Primary outcome timeframe
28 days Post-Injection 1
Results posted on
2022-03-25
Participant Flow
Study participants were enrolled from 07 September 2011 to 08 March 2012 at 2 clinical sites (1 in Colombia and 1 in Peru).
A total of 792 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; 787 participants were vaccinated.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
Participants received the Stamaril® and the CYD dengue vaccine (Injection \[Inj.\] 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Overall Study
STARTED
|
396
|
396
|
|
Overall Study
Vaccinated
|
394
|
393
|
|
Overall Study
COMPLETED
|
364
|
354
|
|
Overall Study
NOT COMPLETED
|
32
|
42
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
Participants received the Stamaril® and the CYD dengue vaccine (Injection \[Inj.\] 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
7
|
5
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
19
|
29
|
|
Overall Study
Serious adverse event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=394 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=393 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Total
n=787 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
394 Participants
n=5 Participants
|
393 Participants
n=7 Participants
|
787 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.2 Months
STANDARD_DEVIATION 0.25 • n=5 Participants
|
12.2 Months
STANDARD_DEVIATION 0.25 • n=7 Participants
|
12.2 Months
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
196 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days Post-Injection 1Population: Analysis was performed on Per-Protocol analysis set which included all participants who had no protocol deviations. Per-Protocol analysis set was defined for the Stamaril® vaccine immune response.
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=296 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=299 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
|
100.0 Percentage of participants
|
99.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 1Population: Analysis performed on Full analysis set included participants who received at least co-administration of Stamaril® vaccine with either 1st dose of CYD dengue vaccine or placebo, had blood sample post-Stamaril® vaccination drawn and a valid test result. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=378 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=376 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
|
98.7 Percentage of participants
|
99.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28-days Post-Injection 1Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=381 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=377 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Pre-Injection 1
|
5.64 Titers (1/dilution)
Interval 5.41 to 5.89
|
5.67 Titers (1/dilution)
Interval 5.42 to 5.93
|
|
Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Post-Injection 1
|
369 Titers (1/dilution)
Interval 322.0 to 423.0
|
423 Titers (1/dilution)
Interval 375.0 to 478.0
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28- days Post-Injection 1Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."
GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=378 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=376 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
|
35.1 Ratio
Interval 30.5 to 40.4
|
39.8 Ratio
Interval 35.3 to 45.0
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28-days Post-Injection 1Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dil) regardless of the flavivirus status of participants at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=381 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=377 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Pre-Injection 1
|
9.0 Percentage of participants
|
9.0 Percentage of participants
|
|
Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Post-Injection 1
|
99.5 Percentage of participants
|
99.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28-days Post-Injections 2 and 3Population: Analysis performed on Full analysis set for dengue immunogenicity which included participants who received at least 1dose of CYD dengue vaccine/placebo, had at least 1 blood sample withdrawn and valid post vaccination test results for at least 1 dengue serotype. Here,'number analyzed' =participants with available data for each specified category.
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=113 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
68.1 Titers (1/dilution)
Interval 54.6 to 84.9
|
29.8 Titers (1/dilution)
Interval 22.1 to 40.2
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
74.0 Titers (1/dilution)
Interval 61.3 to 89.4
|
74.6 Titers (1/dilution)
Interval 62.5 to 89.1
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
5.08 Titers (1/dilution)
Interval 4.92 to 5.25
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
47.3 Titers (1/dilution)
Interval 38.9 to 57.5
|
11.8 Titers (1/dilution)
Interval 9.82 to 14.1
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
89.0 Titers (1/dilution)
Interval 76.4 to 104.0
|
61.3 Titers (1/dilution)
Interval 52.5 to 71.5
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
5.10 Titers (1/dilution)
Interval 4.96 to 5.23
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
95.5 Titers (1/dilution)
Interval 78.0 to 117.0
|
41.1 Titers (1/dilution)
Interval 33.2 to 51.0
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
173 Titers (1/dilution)
Interval 142.0 to 211.0
|
150 Titers (1/dilution)
Interval 127.0 to 177.0
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
5.05 Titers (1/dilution)
Interval 4.95 to 5.16
|
5.18 Titers (1/dilution)
Interval 5.0 to 5.37
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
118 Titers (1/dilution)
Interval 101.0 to 137.0
|
43.4 Titers (1/dilution)
Interval 36.0 to 52.3
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
181 Titers (1/dilution)
Interval 158.0 to 207.0
|
155 Titers (1/dilution)
Interval 136.0 to 176.0
|
|
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.05 Titers (1/dilution)
Interval 4.96 to 5.14
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28-days Post-Injections 2 and 3Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=113 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj.2/Pre-Inj. 1
|
4.78 Titer ratios
Interval 3.91 to 5.84
|
1.15 Titer ratios
Interval 0.973 to 1.37
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Inj.3/Pre-Inj. 1
|
8.82 Titer ratios
Interval 7.55 to 10.3
|
6.14 Titer ratios
Interval 5.26 to 7.18
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj.2/Pre-Inj. 1
|
9.55 Titer ratios
Interval 7.75 to 11.8
|
3.86 Titer ratios
Interval 3.15 to 4.72
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Inj.3/Pre-Inj. 1
|
16.7 Titer ratios
Interval 13.7 to 20.4
|
15.2 Titer ratios
Interval 12.8 to 18.1
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj.2/Pre-Inj. 1
|
11.6 Titer ratios
Interval 9.98 to 13.5
|
4.16 Titer ratios
Interval 3.46 to 5.0
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Inj.3/Pre-Inj. 1
|
18.0 Titer ratios
Interval 15.6 to 20.8
|
15.4 Titer ratios
Interval 13.5 to 17.6
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj.2/Pre-Inj. 1
|
6.82 Titer ratios
Interval 5.44 to 8.55
|
2.89 Titer ratios
Interval 2.15 to 3.89
|
|
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Inj.3/Pre-Inj. 1
|
7.26 Titer ratios
Interval 6.02 to 8.77
|
7.44 Titer ratios
Interval 6.24 to 8.88
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28-days Post-Injections 2 and 3Population: Analysis was performed Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers \>= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=113 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
92.0 Percentage of participants
|
51.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
100.0 Percentage of participants
|
97.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
1.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
97.3 Percentage of participants
|
86.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
0.9 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
100.0 Percentage of participants
|
90.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
91.2 Percentage of participants
|
68.1 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
97.3 Percentage of participants
|
98.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injections 2 and 3Population: Analysis was performed Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=113 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 1
|
3.6 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 2
|
100.0 Percentage of participants
|
93.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 2
|
100.0 Percentage of participants
|
87.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 2
|
94.7 Percentage of participants
|
73.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 3
|
100.0 Percentage of participants
|
98.1 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 2
|
85.8 Percentage of participants
|
41.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 3
|
97.3 Percentage of participants
|
97.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injections 2 and 3Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with \>= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=10 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=14 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
5.96 Titers (1/dilution)
Interval 4.01 to 8.87
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
52.5 Titers (1/dilution)
Interval 25.0 to 110.0
|
17.0 Titers (1/dilution)
Interval 7.63 to 38.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
81.7 Titers (1/dilution)
Interval 47.3 to 141.0
|
59.5 Titers (1/dilution)
Interval 44.6 to 79.5
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
6.14 Titers (1/dilution)
Interval 4.5 to 8.38
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
72.4 Titers (1/dilution)
Interval 47.4 to 111.0
|
74.3 Titers (1/dilution)
Interval 27.6 to 200.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
110 Titers (1/dilution)
Interval 75.5 to 160.0
|
133 Titers (1/dilution)
Interval 95.7 to 186.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
5.74 Titers (1/dilution)
Interval 4.15 to 7.94
|
6.75 Titers (1/dilution)
Interval 5.05 to 9.03
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
102 Titers (1/dilution)
Interval 54.8 to 189.0
|
95.8 Titers (1/dilution)
Interval 61.3 to 150.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
143 Titers (1/dilution)
Interval 89.7 to 227.0
|
126 Titers (1/dilution)
Interval 91.7 to 173.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.41 Titers (1/dilution)
Interval 4.55 to 6.43
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
87.1 Titers (1/dilution)
Interval 36.0 to 210.0
|
109 Titers (1/dilution)
Interval 44.7 to 265.0
|
|
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
77.1 Titers (1/dilution)
Interval 24.0 to 248.0
|
74.3 Titers (1/dilution)
Interval 40.9 to 135.0
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injections 2 and 3Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with \<10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=94 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=90 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
45.9 Titers (1/dilution)
Interval 37.0 to 57.0
|
11.4 Titers (1/dilution)
Interval 9.42 to 13.7
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
86.6 Titers (1/dilution)
Interval 73.0 to 103.0
|
61.8 Titers (1/dilution)
Interval 51.5 to 74.3
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
99.0 Titers (1/dilution)
Interval 78.0 to 126.0
|
39.0 Titers (1/dilution)
Interval 31.4 to 48.5
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
174 Titers (1/dilution)
Interval 139.0 to 218.0
|
157 Titers (1/dilution)
Interval 129.0 to 192.0
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
118 Titers (1/dilution)
Interval 101.0 to 139.0
|
37.9 Titers (1/dilution)
Interval 30.8 to 46.8
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
184 Titers (1/dilution)
Interval 158.0 to 214.0
|
160 Titers (1/dilution)
Interval 138.0 to 187.0
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
66.4 Titers (1/dilution)
Interval 51.8 to 85.1
|
24.0 Titers (1/dilution)
Interval 17.4 to 33.2
|
|
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
73.0 Titers (1/dilution)
Interval 60.0 to 88.7
|
72.2 Titers (1/dilution)
Interval 59.1 to 88.1
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injections 2 and 3Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with \>= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=10 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=14 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
10.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
90.0 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
20.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
100.0 percentage of participants
|
92.9 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
12.5 percentage of participants
|
30.8 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
0.0 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
90.0 percentage of participants
|
92.9 percentage of participants
|
|
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
88.9 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injections 2 and 3Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with \<10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=94 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=90 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
92.6 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
100.0 Percentage of participants
|
96.5 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
96.8 Percentage of participants
|
86.7 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
100.0 Percentage of participants
|
87.8 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
90.4 Percentage of participants
|
63.3 Percentage of participants
|
|
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
97.8 Percentage of participants
|
97.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3Population: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category. "0" in "number analyzed" field= none of the participants were evaluable since participants did not received CYD dengue vaccine as Injection 1 (Placebo group) or Placebo at any time point (CYD dengue vaccine group).
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>39.5°celsius; Vomiting: \>= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=394 Participants
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=393 Participants
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for Stamaril®; Post-Any Inj.
|
25.4 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, Stamaril®;Post-Any Inj
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for CYD dengue;Post-Any Inj.
|
36.5 Percentage of participants
|
28.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj site Tenderness, CYDdengue;Post-Any Inj
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for placebo; Post-Any Inj.
|
—
|
19.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, placebo;Post-Any Inj.
|
—
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for Stamaril®; Post-Any Inj.
|
8.3 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema, Stamaril®;Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for CYD dengue;Post-Any Inj.
|
12.7 Percentage of participants
|
8.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema, CYD dengue;Post-Any Inj
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for placebo; Post-Any Inj.
|
—
|
10.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema for placebo; Post-Any Inj
|
—
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for Stamaril®; Post-Any Inj.
|
4.7 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling, Stamaril®; Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for CYD dengue; Post-Any Inj.
|
7.5 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling, CYD dengue; Post-Any Inj
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for placebo; Post-Any inj.
|
—
|
4.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling for placebo; Post-Any Inj
|
—
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for Stamaril®; Post-Inj. 1
|
25.4 Percentage of participants
|
17.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, Stamaril®; Post-Inj. 1
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for CYD dengue; Post-Inj. 1
|
24.9 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 1
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for placebo; Post-Inj. 1
|
—
|
19.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, placebo; Post-Inj. 1
|
—
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for Stamaril®; Post-Inj. 1
|
8.3 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj.site Erythema for Stamaril®; Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for CYD dengue; Post-Inj. 1
|
8.8 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 1
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for placebo; Post-Inj. 1
|
—
|
10.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema for placebo; Post-Inj. 1
|
—
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for Stamaril®; Post-Inj. 1
|
4.7 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj.site Swelling for Stamaril®; Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for CYD dengue; Post-Inj. 1
|
4.7 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 1
|
0.0 Percentage of participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for placebo; Post-Inj. 1
|
—
|
4.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling for placebo; Post-Inj. 1
|
—
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for CYD dengue; Post-Inj. 2
|
17.0 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for CYD dengue; Post-Inj. 2
|
5.1 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for CYD dengue; Post-Inj. 2
|
2.7 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Tenderness for CYD dengue; Post-Inj. 3
|
14.6 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 3
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema for CYD dengue; Post-Inj. 3
|
3.6 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling for CYD dengue; Post-Inj. 3
|
1.6 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Any Injection
|
48.1 Percentage of participants
|
40.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Any Injection
|
1.3 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Vomiting; Post-Any Injection
|
30.6 Percentage of participants
|
27.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Vomiting; Post-Any Injection
|
1.3 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Crying abnormal; Post-Any Injection
|
47.2 Percentage of participants
|
44.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Crying abnormal; Post-Any Injection
|
0.5 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Drowsiness; Post-Any Injection
|
36.3 Percentage of participants
|
33.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Drowsiness; Post-Any Injection
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Appetite lost; Post-Any Injection
|
54.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Appetite lost; Post-Any Injection
|
4.7 Percentage of participants
|
3.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Irritability; Post-Any Injection
|
46.4 Percentage of participants
|
46.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Irritability; Post-Any Injection
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Injection 1
|
26.7 Percentage of participants
|
16.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Injection 1
|
1.1 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Vomiting; Post-Injection 1
|
16.1 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Vomiting; Post-Injection 1
|
0.5 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Crying abnormal; Post-Injection 1
|
32.9 Percentage of participants
|
32.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Crying abnormal; Post-Injection 1
|
0.5 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Drowsiness; Post-Injection 1
|
24.4 Percentage of participants
|
22.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Drowsiness; Post-Injection 1
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Appetite lost; Post-Injection 1
|
39.6 Percentage of participants
|
33.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Appetite lost; Post-Injection 1
|
4.4 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Irritability; Post-Injection 1
|
38.6 Percentage of participants
|
34.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Irritability; Post-Injection 1
|
1.6 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Injection 2
|
21.2 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Injection 2
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Vomiting; Post-Injection 2
|
12.4 Percentage of participants
|
8.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Vomiting; Post-Injection 2
|
0.5 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Crying abnormal; Post-Injection 2
|
19.7 Percentage of participants
|
21.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Crying abnormal; Post-Injection 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Drowsiness; Post-Injection 2
|
12.7 Percentage of participants
|
16.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Drowsiness; Post-Injection 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Appetite lost; Post-Injection 2
|
27.0 Percentage of participants
|
23.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Appetite lost; Post-Injection 2
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Irritability; Post-Injection 2
|
17.3 Percentage of participants
|
22.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Irritability; Post-Injection 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Injection 3
|
20.3 Percentage of participants
|
17.8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Injection 3
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Vomiting; Post-Injection 3
|
7.4 Percentage of participants
|
7.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Vomiting; Post-Injection 3
|
0.3 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Crying abnormal; Post-Injection 3
|
15.1 Percentage of participants
|
14.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Crying abnormal; Post-Injection 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Drowsiness; Post-Injection 3
|
11.3 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Drowsiness; Post-Injection 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Appetite lost; Post-Injection 3
|
19.8 Percentage of participants
|
18.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Appetite lost; Post-Injection 3
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Irritability; Post-Injection 3
|
14.3 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Grade 3 Irritability; Post-Injection 3
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 35 serious events
Other events: 211 other events
Deaths: 0 deaths
Placebo Group
Serious events: 38 serious events
Other events: 193 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=394 participants at risk
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=393 participants at risk
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Febrile convulsion
|
1.5%
6/394 • Number of events 7 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
1.0%
4/393 • Number of events 4 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Abscess
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Acute sinusitis
|
0.51%
2/394 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Cellulitis
|
0.51%
2/394 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Diarrhoea infectious
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.51%
2/393 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Gastroenteritis viral
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Impetigo
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Pneumonia
|
3.0%
12/394 • Number of events 16 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
2.8%
11/393 • Number of events 11 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Tracheitis
|
0.25%
1/394 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/393 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
4/394 • Number of events 4 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.76%
3/393 • Number of events 3 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Viral infection
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.25%
1/393 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=394 participants at risk
Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
Placebo Group
n=393 participants at risk
Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.6%
26/394 • Number of events 29 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
4.6%
18/393 • Number of events 21 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
24/394 • Number of events 27 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
5.6%
22/393 • Number of events 24 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Drowsiness; Post-Any Injection
|
36.3%
140/386 • Number of events 182 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
33.9%
131/386 • Number of events 183 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Tenderness for Stamaril® vaccine; Post-Any Injection
|
25.4%
98/386 • Number of events 98 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
17.6%
68/386 • Number of events 68 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Tenderness for CYD dengue vaccine; Post-Any Injection
|
36.5%
141/386 • Number of events 212 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
28.9%
105/363 • Number of events 132 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Tenderness for placebo; Post-Any Injection
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
19.7%
76/386 • Number of events 76 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Erythema for Stamaril® vaccine; Post-Any Injection
|
8.3%
32/386 • Number of events 32 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
9.8%
38/386 • Number of events 38 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Erythema for CYD dengue vaccine; Post-Any Injection
|
12.7%
49/386 • Number of events 66 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
8.8%
32/363 • Number of events 44 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Erythema for placebo; Post-Any Injection
|
0.00%
0/394 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
10.7%
42/393 • Number of events 42 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Swelling for CYD dengue vaccine; Post-Any Injection
|
7.5%
29/386 • Number of events 34 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
6.1%
22/363 • Number of events 27 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Fever; Post-Any Injection
|
48.1%
185/385 • Number of events 248 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
40.3%
155/385 • Number of events 199 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Psychiatric disorders
Crying abnormal; Post-Any injection
|
46.2%
182/394 • Number of events 255 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
43.3%
170/393 • Number of events 255 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Psychiatric disorders
Irritability; Post-Any injection
|
45.4%
179/394 • Number of events 265 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
45.5%
179/393 • Number of events 272 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.5%
61/394 • Number of events 73 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
15.0%
59/393 • Number of events 71 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Vomiting; Post-Any injection
|
30.6%
118/386 • Number of events 135 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
27.2%
105/386 • Number of events 124 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Metabolism and nutrition disorders
Appetite lost; Post-Any injection
|
53.6%
211/394 • Number of events 325 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
49.1%
193/393 • Number of events 280 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
11.2%
44/394 • Number of events 46 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
10.9%
43/393 • Number of events 49 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
29.9%
118/394 • Number of events 140 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
30.5%
120/393 • Number of events 140 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Pharyngitis
|
18.5%
73/394 • Number of events 90 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
13.2%
52/393 • Number of events 65 • Adverse events (AE) were collected from Day 0 (post-vaccination) of Month 0 up to 6 months post-Injection 3 (up to 573 days).
A solicited reaction (SR) was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER