Study of ChimeriVax™ Tetravalent Dengue Vaccine in Health... | NCT00788151

ID	Type	Description	Link
2014-001711-40	EudraCT Number

Label	Type	Description	Intervention Names
CYD Dengue vaccine group	Experimental	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).	Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4
Control group	Placebo Comparator	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).	Biological: Pneumococcal polysaccharide vaccine

Name	Type	Description	Arm Group Labels	Other Names
CYD Dengue Vaccine Serotypes 1, 2, 3, and 4	Biological	0.5 mL, Subcutaneous (SC)	CYD Dengue vaccine group

Measure	Description	Time Frame
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.	Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.	Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.	Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

Measure	Description	Time Frame
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo	Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.	Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

Name	Affiliation	Role
Medical Monitor	Sanofi Pasteur SA	Study Director

PubMed Identifier	Type	Citation	Retractions
	Background	Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.
22863660	Result	Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, Saville M, Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012 Sep 7;30(41):5935-41. doi: 10.1016/j.vaccine.2012.07.043. Epub 2012 Jul 31.

Label	URL
Related Info	View source

ID	Title	Description
FG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
FG001	Control Group

ID	Title	Description
BG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
BG001	Control Group	Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000199 BG00199 BG002298

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo

Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.

Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts
Participants	OG000199 OG00199

Title

Denominators

Categories

Inj. site Pain; Post-Inj. 1 (2-11 years)

- ParticipantsOG000199
- ParticipantsOG00199

Title	Measurements
	OG00020.6

Primary

Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Primary

Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

Posted

Number

Percentage of participants

Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Secondary

Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

Analysis was performed on Full analysis set which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution.

Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts
Participants

Secondary

Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units

Secondary

Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts
Participants

Secondary

Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo

GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1 and 28 days Post-Injection 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo

Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 1

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Secondary

GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo

GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1 and 28 days Post-Injection 1

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts
Participants

Secondary

GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo

GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.

Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
OG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Units	Counts

Title

Denominators

Categories

Serotype 1; Pre-Inj. 1, All

- ParticipantsOG000199
- ParticipantsOG00199

Title	Measurements
	OG00018.8(13.8 to 25.6) OG00123.9(15.5 to 36.9)

Serotype 1; 28 days Post-Inj.1, All

- ParticipantsOG000193
- ParticipantsOG00195

Title	Measurements
	OG00043.1(30.0 to 61.9) OG001

Serotype 1; Pre-Inj. 2, All

- ParticipantsOG000189
- ParticipantsOG00192

Title	Measurements
	OG00029.2(20.5 to 41.7) OG001

Serotype 1; 28 days Post-Inj. 2, All

- ParticipantsOG000188
- ParticipantsOG00192

Title	Measurements
	OG000214(171 to 266) OG001

Serotype 1; Pre-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00191

Title	Measurements
	OG00064.1(46.1 to 89.2) OG001

Serotype 1; 28 days Post-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00189

Title	Measurements
	OG000254(203 to 318) OG001

Serotype 2; Pre-Inj. 1, All

- ParticipantsOG000199
- ParticipantsOG00199

Title	Measurements
	OG0007.55(6.50 to 8.78) OG001

Serotype 2; 28 days Post-Inj.1, All

- ParticipantsOG000193
- ParticipantsOG00195

Title	Measurements
	OG00015.5(12.4 to 19.4) OG001

Serotype 2; Pre-Inj. 2, All

- ParticipantsOG000189
- ParticipantsOG00193

Title	Measurements
	OG00011.6(9.52 to 14.1) OG001

Serotype 2; 28 days Post-Inj. 2, All

- ParticipantsOG000188
- ParticipantsOG00192

Title	Measurements
	OG00021.4(17.6 to 25.9) OG001

Serotype 2; Pre-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00191

Title	Measurements
	OG00011.4(9.39 to 13.8) OG001

Serotype 2; 28 days Post-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00189

Title	Measurements
	OG00022.3(18.9 to 26.4) OG001

Serotype 3; Pre-Inj. 1, All

- ParticipantsOG000199
- ParticipantsOG00199

Title	Measurements
	OG00013.1(10.3 to 16.5) OG001

Serotype 3; 28 days Post-Inj.1, All

- ParticipantsOG000193
- ParticipantsOG00195

Title	Measurements
	OG00041.4(30.9 to 55.4) OG001

Serotype 3; Pre-Inj. 2, All

- ParticipantsOG000189
- ParticipantsOG00193

Title	Measurements
	OG00022.6(17.3 to 29.5) OG001

Serotype 3; 28 days Post-Inj. 2, All

- ParticipantsOG000188
- ParticipantsOG00192

Title	Measurements
	OG000128(108 to 150) OG001

Serotype 3; Pre-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00191

Title	Measurements
	OG00031.0(24.3 to 39.6) OG001

Serotype 3; 28 days Post-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00189

Title	Measurements
	OG00099.2(84.8 to 116) OG001

Serotype 4; Pre-Inj. 1, All

- ParticipantsOG000199
- ParticipantsOG00199

Title	Measurements
	OG0007.52(6.37 to 8.87) OG001

Serotype 4; 28 days Post-Inj.1, All

- ParticipantsOG000193
- ParticipantsOG00195

Title	Measurements
	OG00087.9(65.4 to 118) OG001

Serotype 4; Pre-Inj. 2, All

- ParticipantsOG000189
- ParticipantsOG00193

Title	Measurements
	OG00021.3(16.9 to 26.8) OG001

Serotype 4; 28 days Post-Inj. 2, All

- ParticipantsOG000188
- ParticipantsOG00192

Title	Measurements
	OG000158(134 to 186) OG001

Serotype 4; Pre-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00191

Title	Measurements
	OG00039.2(31.7 to 48.5) OG001

Serotype 4; 28 days Post-Inj. 3, All

- ParticipantsOG000186
- ParticipantsOG00189

Title	Measurements
	OG000147(126 to 172) OG001

Serotype 1; Pre-Inj. 1, 2-5 years

- ParticipantsOG000100
- ParticipantsOG00150

Title	Measurements
	OG00020.3(12.9 to 32.0) OG001

Serotype 1; 28 days Post-Inj. 1, 2-5 years

- ParticipantsOG00095
- ParticipantsOG00148

Title	Measurements
	OG00044.8(25.9 to 77.3) OG001

Serotype 1; Pre-Inj. 2, 2-5 years

- ParticipantsOG00093
- ParticipantsOG00145

Title	Measurements
	OG00031.3(18.1 to 53.9) OG001

Serotype 1; 28 days Post-Inj. 2, 2-5 years

- ParticipantsOG00092
- ParticipantsOG00145

Title	Measurements
	OG000281(204 to 386) OG001

Serotype 1; Pre-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00144

Title	Measurements
	OG00065.2(39.6 to 107) OG001

Serotype 1; 28 days Post-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00143

Title	Measurements
	OG000315(228 to 436) OG001

Serotype 2; Pre-Inj. 1, 2-5 years

- ParticipantsOG000100
- ParticipantsOG00150

Title	Measurements
	OG0006.66(5.63 to 7.88) OG001

Serotype 2; 28 days Post-Inj. 1, 2-5 years

- ParticipantsOG00095
- ParticipantsOG00148

Title	Measurements
	OG00012.7(9.35 to 17.3) OG001

Serotype 2; Pre-Inj. 2, 2-5 years

- ParticipantsOG00093
- ParticipantsOG00146

Title	Measurements
	OG00010.1(7.85 to 12.9) OG001

Serotype 2; 28 days Post-Inj. 2, 2-5 years

- ParticipantsOG00092
- ParticipantsOG00145

Title	Measurements
	OG00017.1(13.4 to 21.8) OG001

Serotype 2; Pre-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00144

Title	Measurements
	OG0009.03(7.17 to 11.4) OG001

Serotype 2; 28 days Post-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00143

Title	Measurements
	OG00019.7(15.9 to 24.5) OG001

Serotype 3; Pre-Inj. 1, 2-5 years

- ParticipantsOG000100
- ParticipantsOG00150

Title	Measurements
	OG00011.8(8.54 to 16.4) OG001

Serotype 3; 28 days Post-Inj. 1, 2-5 years

- ParticipantsOG00095
- ParticipantsOG00148

Title	Measurements
	OG00037.4(23.9 to 58.3) OG001

Serotype 3; Pre-Inj. 2, 2-5 years

- ParticipantsOG00093
- ParticipantsOG00146

Title	Measurements
	OG00019.8(13.4 to 29.4) OG001

Serotype 3; 28 days Post-Inj. 2, 2-5 years

- ParticipantsOG00092
- ParticipantsOG00145

Title	Measurements
	OG000129(104 to 160) OG001

Serotype 3; Pre-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00144

Title	Measurements
	OG00026.7(18.7 to 38.2) OG001

Serotype 3; 28 days Post-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00143

Title	Measurements
	OG000108(86.9 to 135) OG001

Serotype 4; Pre-Inj. 1, 2-5 years

- ParticipantsOG000100
- ParticipantsOG00150

Title	Measurements
	OG0007.04(5.67 to 8.74) OG001

Serotype 4; 28 days Post-Inj. 1, 2-5 years

- ParticipantsOG00095
- ParticipantsOG00148

Title	Measurements
	OG000114(74.0 to 176) OG001

Serotype 4; Pre-Inj. 2, 2-5 years

- ParticipantsOG00093
- ParticipantsOG00146

Title	Measurements
	OG00022.3(16.0 to 31.0) OG001

Serotype 4; 28 days Post-Inj. 2, 2-5 years

- ParticipantsOG00092
- ParticipantsOG00145

Title	Measurements
	OG000200(166 to 240) OG001

Serotype 4; Pre-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00144

Title	Measurements
	OG00039.4(29.5 to 52.8) OG001

Serotype 4; 28 days Post-Inj. 3, 2-5 years

- ParticipantsOG00090
- ParticipantsOG00143

Title	Measurements
	OG000176(143 to 217) OG001

Serotype 1; Pre-Inj. 1, 6-11 years

- ParticipantsOG00099
- ParticipantsOG00149

Title	Measurements
	OG00017.4(11.4 to 26.6) OG001

Serotype 1; 28 days Post-Inj. 1, 6-11 years

- ParticipantsOG00098
- ParticipantsOG00147

Title	Measurements
	OG00041.5(25.5 to 67.5) OG001

Serotype 1; Pre-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00027.4(17.2 to 43.6) OG001

Serotype 1; 28 days Post-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG000165(122 to 222) OG001

Serotype 1; Pre-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00063.2(40.5 to 98.7) OG001

Serotype 1;28 days Post-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00146

Title	Measurements
	OG000207(152 to 283) OG001

Serotype 2; Pre-Inj. 1, 6-11 years

- ParticipantsOG00099
- ParticipantsOG00149

Title	Measurements
	OG0008.57(6.67 to 11.0) OG001

Serotype 2; 28 days Post-Inj. 1, 6-11 years

- ParticipantsOG00098
- ParticipantsOG00147

Title	Measurements
	OG00018.8(13.5 to 26.2) OG001

Serotype 2; Pre-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00013.3(9.80 to 18.0) OG001

Serotype 2; 28 days Post-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00026.5(19.7 to 35.7) OG001

Serotype 2; Pre-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00014.1(10.5 to 19.0) OG001

Serotype 2; 28 days Post-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00146

Title	Measurements
	OG00025.0(19.4 to 32.3) OG001

Serotype 3; Pre-Inj. 1, 6-11 years

- ParticipantsOG00099
- ParticipantsOG00149

Title	Measurements
	OG00014.4(10.3 to 20.2) OG001

Serotype 3; 28 days Post-Inj. 1, 6-11 years

- ParticipantsOG00098
- ParticipantsOG00147

Title	Measurements
	OG00045.6(31.0 to 67.1) OG001

Serotype 3; Pre-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00025.6(17.8 to 37.0) OG001

Serotype 3; 28 days Post-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG000126(98.6 to 162) OG001

Serotype 3; Pre-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00035.6(25.3 to 50) OG001

Serotype 3; 28 days Post-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00146

Title	Measurements
	OG00091.3(73.0 to 114) OG001

Serotype 4; Pre-Inj. 1, 6-11 years

- ParticipantsOG00099
- ParticipantsOG00149

Title	Measurements
	OG0008.03(6.23 to 10.3) OG001

Serotype 4; 28 days Post-Inj. 1, 6-11 years

- ParticipantsOG00098
- ParticipantsOG00147

Title	Measurements
	OG00068.2(45.6 to 102) OG001

Serotype 4; Pre-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00020.3(14.6 to 28.1) OG001

Serotype 4; 28 days Post-Inj. 2, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG000126(96.3 to 164) OG001

Serotype 4; Pre-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00147

Title	Measurements
	OG00039.0(28.6 to 53.2) OG001

Serotype 4; 28 days Post-Inj. 3, 6-11 years

- ParticipantsOG00096
- ParticipantsOG00146

Title	Measurements
	OG000125(98.9 to 157) OG001

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Food poisoning	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected99 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 events0 affected199 at risk EG0012 events1 affected99 at risk
Vascular purpura	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected99 at risk
Epiphyseal disorder	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 events1 affected199 at risk EG0010 events0 affected99 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected99 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0000 events0 affected199 at risk EG0011 events1 affected99 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site Pain; Post-injection 1, All participants	General disorders	MedDRA 11.0	Systematic Assessment	EG00041 events41 affected199 at risk EG00117 events17 affected99 at risk
Injection site Erythema; Post-injection 1, All participants	General disorders	MedDRA 11.0	Systematic Assessment	EG00015 events15 affected199 at risk EG0014 events4 affected99 at risk
Injection site Swelling; Post-injection 1, all participants	General disorders	MedDRA 11.0	Systematic Assessment	EG00011 events11 affected199 at risk EG0015 events5 affected99 at risk
Injection site Pain; Post-injection 2, All participants	General disorders	MedDRA 11.0	Systematic Assessment	EG00037 events37 affected188 at risk EG00116 events16 affected92 at risk
Injection site Pain; Post-injection 3, All participants	General disorders	MedDRA 11.0	Systematic Assessment	EG00033 events33 affected186 at risk EG00129 events29 affected90 at risk
Injection site Erythema; Post-injection 3, All participants	General disorders	MedDRA 11.0	Systematic Assessment	EG0008 events8 affected186 at risk EG00110 events10 affected90 at risk
Injection site Swelling; Post-injection 3, All participants	General disorders	MedDRA 11.0	Systematic Assessment	EG0006 events6 affected186 at risk EG0018 events8 affected90 at risk

ID	Term
D003715	Dengue
D019595	Severe Dengue

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections
D014777	Virus Diseases
D018177	Flavivirus Infections
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006482	Hemorrhagic Fevers, Viral

ID	Term
C445780	ChimeriVax
D022242	Pneumococcal Vaccines
C414006	23-valent pneumococcal capsular polysaccharide vaccine

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CYD Dengue Vaccine Group	Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).	0	199	2	199	71	199
EG001	Control Group	Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).	0	99	4	99	29	99

ID	Term
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures