| Primary | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | Geometric Mean Titers (GMTs) of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT). | Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD64). Here, 'number analyzed' = participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | | 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64). | | OG001 | CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). |
| | | Title | Denominators | Categories |
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| Dengue Virus Serotype 1 | - ParticipantsOG000176
- ParticipantsOG001177
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Geometric mean of titer ratio | 1.66 | | | 2-Sided | 95 | 1.33 | 2.06 | | | | | Non-Inferiority | The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (>) 1/2 for each serotype. | | |
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| Secondary | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. | Analysis was performed on Full analysis set which included all participants who received either CYD Dengue Vaccine or placebo and had blood sample drawn and valid post-injection serology results. Here, 'number analyzed' = participants with available data for each specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | | 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64). | | OG001 | CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). |
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| Secondary | GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. | Analysis was performed on Per-Protocol Analysis Set. | Posted | | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | | Pre-booster injection (Day 0) and 28 days post-booster injection | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection. | Analysis was performed on Per-Protocol Analysis Set. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Pre-booster injection (Day 0) and 28 days post-booster injection | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers greater than or equal to (>=)10 (1/dilution). | Analysis was performed on Per-Protocol Analysis Set. | Posted | | Number | | percentage of participants | | Pre-booster injection (Day 0) and 28 days post-booster injection | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Seroconversion for each serotype was defined as the percentage of participants with either a pre-booster titer <10 (1/dilution) and a post-booster titer >=40 (1/dilution), or a pre-booster titer >=10 (1/dilution) and a >=4-fold increase in post-booster titer as determined by PRNT. | Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category. | Posted | | Number | | percentage of participants | | 28 days post-booster injection | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. | 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) | | 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. GMTRs were calculated as the ratio of GMTs pre-booster injection and post-dose injection. | 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 | ratio | | 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution). | Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. | Posted | | Number | | percentage of participants | | 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. | 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) | | 6 months,12 months, and 24 months post-booster injection in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection. | 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 | ratio | | Pre-booster injection (Day 0), 6 months, 12 months, and 24 months post-booster injection in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution). | Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. | Posted | | Number | | percentage of participants | | 6 months,12 months, and 24 months post-booster injection in CYD64 | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 millimeters (mm). | Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo. | Posted | | Count of Participants | | Participants | | Within 7 days after booster injection | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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| Secondary | Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >=39°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 specified category. | Posted | | Count of Participants | | Participants | | Within 14 days after booster injection | | | | ID | Title | Description |
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| OG000 | CYD Dengue Vaccine Booster Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). | | OG001 | Placebo Group | Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). |
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