Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy S... | NCT00880893

ID	Type	Description	Link
2014-001713-26	EudraCT Number

Label	Type	Description	Intervention Names
CYD Dengue Vaccine Group	Experimental	Participant's received the CYD Dengue Vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.	Biological: CYD Dengue vaccine
Placebo Group	Sham Comparator	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >= 12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.	Biological: NaCl + influenza virus or hepatitis A vaccine

Name	Type	Description	Arm Group Labels	Other Names
CYD Dengue vaccine	Biological	0.5 mL, Subcutaneous on Day 0, Months 6 and 12	CYD Dengue Vaccine Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo	Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, >=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: >=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: >10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, >=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.	Day 0 up to 14 days post-any and each injection
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 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. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.	Day 0 up to 14 days post-each injection
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo	Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).	Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo	Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo	Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Aged from 2 to 45 years on the day of inclusion.
Participant in good health, based on medical history and physical examination.
Provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years.
Participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.

Exclusion Criteria :

Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
Breast-feeding woman.
Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
Personal or family history of thymic pathology or myasthenia.
Previous hepatitis A vaccination (for children only).
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy.
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the 18 coming months.
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures.
Participant who plans to move to another country within the 18 coming months.

Name	Affiliation	Role
Medical Director	Sanofi Pasteur Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
23839107	Result	Harenberg A, Begue S, Mamessier A, Gimenez-Fourage S, Ching Seah C, Wei Liang A, Li Ng J, Yun Toh X, Archuleta S, Wilder-Smith A, Shek LP, Wartel-Tram A, Bouckenooghe A, Lang J, Crevat D, Caillet C, Guy B. Persistence of Th1/Tc1 responses one year after tetravalent dengue vaccination in adults and adolescents in Singapore. Hum Vaccin Immunother. 2013 Nov;9(11):2317-25. doi: 10.4161/hv.25562. Epub 2013 Jul 9.
22894958

Label	URL
Related Info	View source

ID	Title	Description
FG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
FG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

ID	Title	Description
BG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
BG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000898 BG001300 BG0021198

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 All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo

Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, >=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: >=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: >10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, >=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.

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

Posted

Number

Percentage of participants

Day 0 up to 14 days post-any and each injection

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Units	Counts
Participants	OG000898 OG001300

Title

Denominators

Categories

Injection site Pain; Post-Any Injection

- ParticipantsOG000892
- ParticipantsOG001297

Title	Measurements
	OG00053.9

Primary

Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 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. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.

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

Posted

Number

Percentage of participants

Day 0 up to 14 days post-each injection

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Units	Counts
Participants

Primary

Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Analysis was performed on Per-Protocol (PP) analysis set which included all participants who were vaccinated and had no protocol deviations. Here, 'number analyzed' = participants with available data for each specified category.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Primary

Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Primary

Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Posted

Number

Percentage of participants

Pre-Injection 1 and 28 days Post-Injection 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Primary

Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo

GMTs against each serotype with the parental dengue virus strains were assessed using a dengue PRNT assay.

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

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

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

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Units	Counts
Participants

Primary

GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine

GMTs against each dengue virus serotype (parental strains) were assessed using a dengue PRNT assay.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1 and 28 days Post-Injection 3

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Units	Counts

Secondary

Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Full analysis set included participants who received at least 1 dose of CYD dengue vaccine or Placebo, had at least 1 blood sample drawn and valid post-vaccination serology result. Here, 'overall number of participants analyzed'=participants evaluable for outcome measure and 'number analyzed'=participants with available data for specified category.

Posted

Number

Percentage of participants

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers >=10 (1/dilution).

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

Posted

Number

Percentage of participants

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Posted

Number

Percentage of participants

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).

Posted

Number

Percentage of participants

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo

Posted

Number

Percentage of participants

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo

Posted

Number

Percentage of participants

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine

GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo

GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo

GMTs against each serotype with the dengue virus strain were assessed using a dengue PRNT assay.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dilution)

Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.

Posted

Number

Percentage of participants

28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.

Posted

Number

Percentage of participants

28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.

Posted

Number

Percentage of participants

28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each serotype with the dengue virus strain were assessed using a PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.

Posted

Number

Percentage of participants

28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.

Posted

Number

Percentage of participants

28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Secondary

Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo

Posted

Number

Percentage of participants

28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)

ID	Title	Description
OG000	CYD Dengue Vaccine Group	Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
OG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Osteotomy	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Ruptured ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Adverse drug reaction	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Chest pain	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 events2 affected898 at risk EG0012 events1 affected300 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Migraine	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 events2 affected898 at risk EG0010 events0 affected300 at risk
Radial nerve palsy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Syncope vasovagal	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Tension headache	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0011 events1 affected300 at risk
Colitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Gingivitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0012 events1 affected300 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Thyroid disorder	Endocrine disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Appendicitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 events2 affected898 at risk EG0010 events0 affected300 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Conjunctivitis viral	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 events2 affected898 at risk EG0010 events0 affected300 at risk
Corneal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Dengue fever	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 events3 affected898 at risk EG0010 events0 affected300 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 events2 affected898 at risk EG0011 events1 affected300 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0012 events2 affected300 at risk
Groin abscess	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 events2 affected898 at risk EG0010 events0 affected300 at risk
Herpangina	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Meningitis viral	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 events0 affected898 at risk EG0011 events1 affected300 at risk
Pharyngitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0011 events1 affected300 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0011 events1 affected300 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 events2 affected898 at risk EG0010 events0 affected300 at risk
Viral infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 events1 affected898 at risk EG0010 events0 affected300 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00048 events42 affected898 at risk EG00117 events15 affected300 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00047 events42 affected898 at risk EG00115 events15 affected300 at risk
Headache; Post-Any Injection	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG000402 events402 affected891 at risk EG001114 events114 affected297 at risk
Injection site Pain; Post-Any Injection	General disorders	MedDRA (11.0)	Systematic Assessment	EG000481 events481 affected892 at risk EG001198 events198 affected297 at risk
Injection site Erythema; Post-Any Injection	General disorders	MedDRA (11.0)	Systematic Assessment	EG00064 events64 affected891 at risk EG00145 events45 affected297 at risk
Injection site Swelling; Post-Any Injection	General disorders	MedDRA (11.0)	Systematic Assessment	EG00037 events37 affected892 at risk EG00125 events25 affected297 at risk
Fever; Post-Any Injection	General disorders	MedDRA (11.0)	Systematic Assessment	EG000101 events101 affected892 at risk EG00122 events22 affected297 at risk
Malaise; Post-Any Injection	General disorders	MedDRA (11.0)	Systematic Assessment	EG000372 events372 affected891 at risk EG001105 events105 affected297 at risk
Asthenia; Post-Any Injection	General disorders	MedDRA (11.0)	Systematic Assessment	EG000183 events183 affected891 at risk EG00152 events52 affected297 at risk
Myalgia; Post-Any Injection	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG000394 events394 affected891 at risk EG001130 events130 affected297 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG00077 events72 affected898 at risk EG00130 events27 affected300 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Singapore		119074	Singapore

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
D022362	Hepatitis A Vaccines
D012965	Sodium Chloride
C478242	vaxigrip

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

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 the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.	3	898	43	898	481	898
EG001	Placebo Group	All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.	0	300	13	300	198	300